Running Head: SECURITY MODEL 1
SECURITY MODEL 7
SECURITY MODEL
Institution Affiliation
Student Name
Date
Abstract
The concept of trusted computing has been in existence for a very long time. It has had an influence on security systems and solutions. In this paper, I will explain the history of TCB. Ways to implement trusted base computing. I will also explain some of the barriers and how to bypass them.
Introduction
The trusted computing base contains hardware, firmware and software that are essential in establishing as well as maintaining security. Moreover, it also includes an operating system with all specific system hardware, in-built security control, software and network hardware, (Ranganathan, 2017). When designing a trusted computing base provision such as access control, giving privileges, user authentication support, authorization of particular processes or systems, backing up information and protection against viruses and malware. It is the responsibility of a trusted computing base to maintain the integrity and confidentiality of information. It monitors the input and output operations.
History
In December 1985, the United States Department of Defense put out the trusted computing system evaluating criteria that well-defined TCB. TCB can be understood when it performs as a centralized, trusted entity, (Scott-Nash, et al., 2016). The structures that get the uppermost level security accredited and certification have a centralized system design. The TCSEC accepted the view of peer trusted nodes describing them as members of the NTCB which protects the network system including the firmware, software and hardware. This combination is responsible for enforcing a security policy.
How is the model implemented?
TCB contains four security mechanisms, including authentication and identification, auditing, labelling and security policy. In order to understand how TCB is implemented and work. Let’s take the example of a bank—one of the most trusted icons in society today. When we make deposits, the money is recorded and safeguarded. It will be available when we want it back. We hardly consider the security mechanism in the back since we trust the banking system. All the mechanisms of TCB are in place. Before withdrawing money from the account, one is required to identify and authenticate themselves to the teller with the account number and signature. There is also discretionary access control that is who is authorized to withdraw money from the account. There are very few clerical problems since all the transactions that take place are audited. In development, the environment has to enforce the security model. Other concepts that are used when developing TCB include memory protection and handle, (Noorman, et al., 2019). This falls under the NIST requirement for assurance. When implementing TCB, it is essential to ensure that the application meets the basic requirements of NIST.
Barriers
The first barr.
Blooming Together_ Growing a Community Garden Worksheet.docx
Running Head SECURITY MODEL 1SECURITY MODEL 7.docx
1. Running Head: SECURITY MODEL 1
SECURITY MODEL 7
SECURITY MODEL
Institution Affiliation
Student Name
Date
Abstract
The concept of trusted computing has been in existence for a
very long time. It has had an influence on security systems and
solutions. In this paper, I will explain the history of TCB. Ways
to implement trusted base computing. I will also explain some
of the barriers and how to bypass them.
2. Introduction
The trusted computing base contains hardware, firmware and
software that are essential in establishing as well as maintaining
security. Moreover, it also includes an operating system with all
specific system hardware, in-built security control, software and
network hardware, (Ranganathan, 2017). When designing a
trusted computing base provision such as access control, giving
privileges, user authentication support, authorization of
particular processes or systems, backing up information and
protection against viruses and malware. It is the responsibility
of a trusted computing base to maintain the integrity and
confidentiality of information. It monitors the input and output
operations.
History
In December 1985, the United States Department of Defense put
out the trusted computing system evaluating criteria that well-
defined TCB. TCB can be understood when it performs as a
centralized, trusted entity, (Scott-Nash, et al., 2016). The
structures that get the uppermost level security accredited and
certification have a centralized system design. The TCSEC
accepted the view of peer trusted nodes describing them as
members of the NTCB which protects the network system
including the firmware, software and hardware. This
combination is responsible for enforcing a security policy.
How is the model implemented?
TCB contains four security mechanisms, including
authentication and identification, auditing, labelling and
3. security policy. In order to understand how TCB is implemented
and work. Let’s take the example of a bank—one of the most
trusted icons in society today. When we make deposits, the
money is recorded and safeguarded. It will be available when
we want it back. We hardly consider the security mechanism in
the back since we trust the banking system. All the mechanisms
of TCB are in place. Before withdrawing money from the
account, one is required to identify and authenticate themselves
to the teller with the account number and signature. There is
also discretionary access control that is who is authorized to
withdraw money from the account. There are very few clerical
problems since all the transactions that take place are audited.
In development, the environment has to enforce the security
model. Other concepts that are used when developing TCB
include memory protection and handle, (Noorman, et al., 2019).
This falls under the NIST requirement for assurance. When
implementing TCB, it is essential to ensure that the application
meets the basic requirements of NIST.
Barriers
The first barrier is that the design can be fundamentally flawed
since they expose society to new threats of non-consumer
behaviour. Manufacturers can secretly implement them
incorrectly. Another barrier is third party uncertainty
concerning the software environment. Even thou the hardware is
implemented in accordance with the specification, it will be
used in a way that will harm the computer owner, (Moon, et al.,
2019). Although TCB provides security benefits, they may
include features that can detriment and abuse the clients who
have been requested to adopt the technology. Security design
mainly involves specifying a threat model. Determine the kind
of threat and the type of attacker the security model prevents
against. A security measure that prevents one attack can be
ineffective from another kind of attack.
How to bypass barriers and other pertinent information?
Attestation is appropriate for preventing the software on the
computer from being changed without the knowledge or consent
4. of the computer owner. These barriers can be bypassed through
owner override. Lack of computer owner control of the
verification content can be a major issue. Owner override fixes
the issue by restoring another inability to determine the
software that is running, (Jomaa, et al., 2018). Attestation only
informs the parties whether the software on the computer has
been altered. Attestation, as well as Owner override, can be
used by the parties to determine whether the software in the
computers has altered without their consent. One of the main
advantages of using Attestation together with Owner override is
that a company can enforce or implement policies against its
own members or employees as long as they are using computers
owned by the company. Owners of computer retain control over
local software.
Conclusion
TCB contains four security mechanisms, including
authentication and identification, auditing, labelling and
security policy. The trusted computing base contains hardware,
firmware and software that are essential in establishing as well
as maintaining security. Some of the barriers include the design
can be fundamentally flawed since they expose society to new
threats of non-consumer behaviour. Manufacturers can secretly
implement them incorrectly. Another barrier is third party
uncertainty concerning the software environment. These barriers
can be bypassed through owner override, (Hardjono & Smith,
2019). Lack of computer owner control of the verification
content can be a major issue. Owner override fixes the issue by
restoring another inability to determine the software that is
running. Attestation only informs the parties whether the
software on the computer has been altered. Attestation, as well
as Owner override, can be used by the parties to determine
whether the software in the computers has altered without their
consent. One of the main advantages of using Attestation
together with Owner override is that a company can enforce or
implement policies against its own members or employees as
long as they are using computers owned by the company.
5. Reference
Hardjono, T., & Smith, N. (2019). Decentralized trusted
computing base for blockchain infrastructure security. arXiv
preprint arXiv:1905.04412. Retrieved from
https://arxiv.org/abs/1905.04412
Jomaa, N., Torrini, P., Nowak, D., Grimaud, G., & Hym, S.
(2018, July). Proof-oriented design of a separation kernel with
minimal trusted computing base. Retrieved from
https://hal.archives-ouvertes.fr/hal-01816830/
Moon, Y. H., Kim, D. W., Kim, Y. S., Yoon, S. Y., Han, J. H.,
Kim, J. N., & Lim, J. D. (2019). U.S. Patent Application No.
16/204,802. Retrieved from
https://patents.google.com/patent/US20190163910A1/en
Noorman, J., Agten, P., Daniels, W., Strackx, R., Van
Herrewege, A., Huygens, C., ... & Piessens, F. (2019). Sancus:
Low-cost trustworthy extensible networked devices with a zero-
software trusted computing base. In Presented as part of the
22nd {USENIX} Security Symposium ({USENIX} Security
13) (pp. 479-498). Retrieved from
https://www.usenix.org/conference/usenixsecurity13/technical-
sessions/presentation/noorman
6. Ranganathan, K. (2017). U.S. Patent No. 7,313,679.
Washington, DC: U.S. Patent and Trademark Office. Retrieved
from https://patents.google.com/patent/US7313679B2/en
Scott-Nash, M. E., Dasari, A., & Wiseman, W. M. (2016). U.S.
Patent No. 9,461,994. Washington, DC: U.S. Patent and
Trademark Office. Retrieved from
https://www.usenix.org/conference/usenixsecurity13/technical-
sessions/presentation/noorman
R E S E A R C H I N B R I E F
The effect of ambulation after cardiac catheterization on patient
outcomes
Sek Ying Chair MBA, PhD, RN
Assistant Professor, The Nethersole School of Nursing, The
Chinese University of Hong Kong, Hong Kong, China
David R Thompson PhD, MBA, RN, FRCN, FESC
Director and Professor of Clinical Nursing, The Nethersole
School of Nursing, The Chinese University of Hong Kong, Hong
Kong, China
Shu Kin Li MBBS, FRCP
7. Chief of Service, Department of Medicine, Pamela Youde
Nethersole Eastern Hospital, Hong Kong, China
Submitted for publication: 24 August 2005
Accepted for publication: 26 January 2006
Introduction
Cardiac catheterization remains the most definitive procedure
for diagnosis and evaluation of coronary artery disease
(Woods et al. 2005). Currently, cardiac catheterization has
become a routine diagnostic procedure performed in many
hospitals in Hong Kong. Although it can be performed
through brachial, radial, or femoral arteries (Woods et al.
2005), the transfemoral puncture is the most common
approach (Noto et al. 1991, Chair et al. 2003). However,
because vascular complications occur in 0Æ43–5Æ8% of
transfemoral cardiac catheterization patients (Noto et al.
1991, Lehmann et al. 1997, Chair et al. 2003), strict bed rest
and immobilization of the catheterized leg have been consid-
ered essential to reduce the risk of their development
(Grossman 1980, Woods et al. 2005). The recommended
8. bed rest duration after transfemoral cardiac catheterization
varies from two to 24 hours (Baum & Gantt 1996, Chair
et al. 2003). Many patients find it difficult to use the bedpan
or urinal in the recumbent position during bed rest, more-
over, studies reported that back pain severity increased with
longer duration of bed rest after cardiac catheterization
(Barkman & Lunse 1994, Baum & Gantt 1996, Chair et al.
2003). Therefore, to obtain optimal patient outcomes, the
length of bed rest duration after cardiac catheterization
should be minimized.
Aims
The aims of this study were to compare patient outcomes of
vascular complications, back pain, and urinary discomfort
between patients ambulated at four and 12–24 hours (usual
care) post-transfemoral cardiac catheterization.
Methods
Patients admitted for elective cardiac catheterization at a
general hospital in Hong Kong Island were recruited to the
9. study. Inclusion criteria were that patients should be ethnic
Chinese, aged over 18 years, had no bleeding disorders, were
not receiving anti-coagulant therapy within the previous
24 hours before the procedure, had no back pain, blood
pressure <180/110 mmHg before the procedure and no
complications developed during cardiac catheterization.
Patients were randomly assigned to either a control or
experimental group according to a computer-generated
random table of number. Patients in the experimental group
were ambulated after four hours bed rest postcardiac
catheterization, whereas patients in the control group were
ambulated the morning after the procedure, 12–24 hours
Correspondence: Sek Ying Chair, The Nethersole School of
Nursing,
The Chinese University of Hong Kong, Shatin, New Territories,
Hong Kong, China. Tel: (852) 2609 6225, E-mail:
[email protected]
edu.hk
� 2007 Blackwell Publishing Ltd
212 doi:10.1111/j.1365-2702.2006.01599.x
10. after bed rest depending on the time the patient had the
procedure completed during the day (usual care).
The puncture site was assessed for vascular complications
hourly for the first six hours then the next morning at
08:00 hours using the guidelines (Christenson et al. 1976).
Significant bleeding was defined as blood loss estimated at
>100 ml, haematoma >5 cm in width or bleeding that led to
further attempts to reestablish haemostasis by manual pres-
sure, sandbag, or reinforcement of pressure dressing. For all
patients, back pain was assessed at four hours, eight hours and
the next morning at 08:00 hours after cardiac catheterization
by using a visual analogue scale consisting of a 100-mm long
line with the left anchor representing ‘no pain’, and the right
anchor representing ‘the worst possible pain’. Urinary discom-
fort was assessed at six hours after the procedure by use of a
five-point Likert scale self-developed measurement consisting
of four questions, a higher value referring to more urinary
11. discomfort. The test–retest reliability of the urinary discomfort
measurement on 18 subjects was significantly correlated
(r ¼ 0Æ95, P < 0Æ001), and the Cronbach’s alpha was 0Æ876.
Findings
A total of 86 (male, n ¼ 41; female, n ¼ 45) subjects
completed the study, 43 in each group with a mean age of
63 years (SD ¼ 9Æ6, range 34–75). Fifty-six (65%) subjects
had either received no formal education or were educated at
elementary level, and eight (9Æ3%) had received a college
education. Most (65Æ1%) subjects had a monthly family
income <HK$8000 (approximately US$1000). Seventy-one
patients (82Æ6%) were either retired or housewives. Table 1
shows that the two groups were not significantly different in
age, gender, education level, and monthly household income.
Occupation status was significantly different between the two
groups (chi-square, P ¼ 0Æ009) with more retired subjects in
the control groups but more housewives in the experimental
group.
There was no difference between the two groups on vascular
12. complications. One subject in the control and none in the
experimental group developed bleeding at the puncture site
that required manual pressure to re-establish haemostasis
(Fisher’s exact test, P ¼ 1). Repeated measures analysis of
variance was used to evaluate the back pain experienced across
time and between groups. There was a significant difference
between the two groups at the three time intervals on back
pain intensity (F2,83 ¼ 9Æ80, P < 0Æ001) with the control
group reporting more pain at each time interval. Moreover,
the two groups also differed significantly on urinary discom-
fort (t65Æ6 ¼ 3Æ24, P ¼ 0Æ006) with the control group
experi-
encing higher levels of urinary discomfort (Table 1).
Table 1 Demographic and outcomes comparisons between
groups
Control (n ¼ 43) Experimental (n ¼ 43) P-value Statistical test
used
Age [years: mean (SD)] 63Æ2 (±9Æ7) 62Æ7 (±9Æ7) 0Æ816 t-
Test
Gender, n (%)
Male 19 (44Æ2) 22 (51Æ2) 0Æ517 Chi-square
Female 24 (55Æ8) 21 (48Æ8)
Educational level, n (%)
13. No formal education 11 (25Æ6) 12 (17Æ9) 0Æ729 Mann–
Whitney U-test
Primary school 16 (37Æ2) 17 (39Æ6)
Secondary school 13 (30Æ2) 9 (20Æ9)
University 3 (7) 5 (11Æ6)
Monthly household income, n (%)
£HK$8000 22 (51Æ2) 34 (79) 0Æ052 Mann–Whitney U-test
HK$8001–$18 000 14 (32Æ6) 6 (14)
>HK$18 001 7 (16Æ2) 3 (7)
Occupation, n (%)
Retired 30 (69Æ8) 21 (48Æ8) 0Æ009 Chi-square
Housewife 4 (9Æ3) 16 (37Æ2)
Presently working 9 (20Æ9) 6 (14)
Vascular complications, n (%) 1 (2Æ3) 0 (0) 1Æ00 Fisher’s
exact test
Back pain
Four hours 1Æ55 0Æ97 <0Æ001 Repeated measure of
ANOVAANOVA
Eight hours 4Æ41 1Æ34
The next morning 4Æ01 1Æ77
Urinary discomfort 2Æ57 1Æ09 0Æ006 t-Test
Research in brief
� 2007 Blackwell Publishing Ltd, Journal of Clinical Nursing,
16, 212–214 213
14. Discussion
Prolonged bed rest in the supine position is difficult for many
patients who have undergone cardiac catheterization. Some
patients complain of back pain and have the desire to move
from side to side. Others complain of difficulty to urinate in a
supine position. In this study, patients allowed to ambulate at
four hours postcardiac catheterization experienced signifi-
cantly less back pain and less urinary discomfort, but did
not experience any increase in vascular complications at
puncture site.
The average age, high unemployment rate, low education
standard and low-income level of patients in this study was
reflective of the study site which is less affluent than the
general Hong Kong population
Implications for practice
The results suggests that early ambulation may play a
substantial role in reducing back pain and urinary discomfort
in post-transfemoral cardiac catheterization. Allowing pa-
15. tients to get out of bed after four hours of bed rest following
cardiac catheterization could be introduced into routine
practice in Hong Kong, as it was found to be safe and might
aid in promoting patient comfort without increasing the
incidence of vascular complications. In addition, the shorter
bed rest duration may reduce the nursing time needed for
administering analgesics or back rubs to relieve back pain.
Early ambulation after cardiac catheterization may also
reduce the nursing time needed for assisting patients to use
urinal and bedpan during bed rest period after the procedure.
References
Barkman A & Lunse C (1994) The effect of early ambulation on
patient comfort and delayed bleeding after cardiac angiogram: a
pilot study. Heart & Lung 23, 112–117.
Baum RA & Gantt DS (1996) Safety of decreasing bedrest after
coronary angiography. Catheterization and Cardiovascular Diag-
nosis 39, 230–233.
Chair SY, Taylor-Piliae RE, Lam G & Chan S (2003) Effect of
16. po-
sitioning on back pain after coronary angiography. Journal of
Advanced Nursing 42, 470–478.
Christenson R, Staab E, Burko H & Foster J (1976) Pressure
dres-
sings and postarteriographic care of the femoral puncture site.
Radiology 119, 97–99.
Grossman W (1980) Cardiac Catheterization and Angiography.
Lea
& Febiger, Philadelphia, PA.
Lehmann KG, Feris ST & Heath-Lange SJ (1997) Maintenance
of
hemostasis after invasive cardiac procedures: implications for
outpatient catheterization. Journal of American College of
Cardi-
ology 30, 444–451.
Noto T, Johnson LW, Krone R, Weaver WF, Clark DA, Kramer
JR
& Vetrovec GW (1991) Cardiac catheterization 1990: a report
of
the registry of the society for cardiac angiography and interven-
17. tions (SCA&I). Catheterization and Cardiovascular Diagnosis
24,
75–83.
Woods SL, Froelicher ESS, Motzer SU & Bridges EJ (2005)
Cardiac
Nursing, 5th edn. Lippincott, Philadelphia, PA.
Research in brief
214 � 2007 Blackwell Publishing Ltd, Journal of Clinical
Nursing, 16, 212–214
PAGE 106 JOURNAL OF VASCULAR NURSING
SEPTEMBER 2016
www.jvascnurs.net
Evaluation of feasibility and safety of
changing body position after transfemoral
angiography: A randomized clinical trial
Sina Valiee, PhD, Mohammad Fathi, PhD, Nooshin Hadizade,
MD, Daem Roshani, PhD, and Parvin Mahmoodi, MS
From t
Kurdista
Nursing
Kurdista
Departm
Departm
Sanand
Univers
18. Corresp
Commit
Street, S
Funding
Kurdista
31229/1
1062-03
Copyrig
http://dx
Background: Considering the growing number of patients who
suffer from cardiovascular and coronary artery disease
and the significant importance of angiography in the diagnosis
of coronary artery disease, this study investigated the ef-
fects of position change on the acute complications of coronary
angiography.
Methods: This study was a randomized clinical trial. Sixty
patients undergoing coronary angiography, which was per-
formed by a single operator were selected by convenience
sampling method and were assigned to intervention or control
groups by randomized block design (30 cases in each group).
Intervention group patients’ position was changed according
to schedule, whereas patients in the control group remained in
the supine position in complete bed rest. At the entrance
hours, 3, 6, 8, and 24 hours after the angiography, patients in
19. both groups were evaluated in terms of vascular complica-
tions, urinary retention, low back pain, groin pain, and comfort.
Data were analyzed by repeated measures, Friedman,
Mann–Whitney, chi-square, independent t-test, and
Kolmogorov–Smirnov tests with SPSS-22.
Results: The two groups did not show any significant difference
in terms of demographic, clinical, and preinterventional
catheterization characteristics (P > 0.05). There was no
significant difference with regard to vascular complications
including hematoma (P = 0.149), bleeding (P > 0.01), bruise (P
= 0.081), and thrombosis in the two groups of patients
during 5 consecutive reviews. However, there was a significant
statistical difference regarding low back pain
(P < 0.001), groin pain (P < 0.001), urinary retention (P = 0.02),
and comfort (P < 0.001).
Conclusions: The results of this study showed that changing the
positions of patients after angiography based on the
provided program created no change in the incidence of
vascular complications (hematoma, bleeding, thrombosis, and
bruise) but resulted in reduced severity of back pain, groin pain,
urinary retention, and increased patients’ comfort. (J
Vasc Nurs 2016;34:106-115)
Cardiovascular disease is one of the leading causes of death
for women and men of all ethnicities and races,1 and it is ex-
pected to remain the most common cause of death in the world
20. until 2020.2 Among heart disease, coronary artery diseases is
the most common and life-threatening one.3
he Social Determinants of Health Research Center,
n University of Medical Sciences, Sanandaj, Iran;
Department, School of Nursing & Midwifery,
n University of Medical Sciences, Sanandaj, Iran;
ent of Epidemiology and Biostatistics, Medicine
ent, Kurdistan University of Medical Sciences,
aj, Iran; Student Research Committee, Kurdistan
ity of Medical Sciences, Sanandaj, Iran.
onding author: Parvin Mahmoodi, MS, Student Research
tee, Kurdistan University of Medical Sciences, Pasdaran
anandaj, Iran (E-mail: [email protected]).
: This work was supported by the Research Council of
n University of Medical Sciences (grant number 1035/
4).
03/$36.00
ht � 2016 by the Society for Vascular Nursing, Inc.
.doi.org/10.1016/j.jvn.2016.05.001
There are different diagnostic methods for assessing coronary
artery disease.4 Coronary angiography is the golden standard
test
to identify the presence and extent of atherosclerotic disease of
coronary artery.5 Annually, nearly three million cardiac
catheter-
izations are done in the United States of America.6
Angiography
involves injecting a radiopaque dye into the coronary arteries
un-
21. der fluoroscopy which determines the condition of the coronary
arteries and the degree of atherosclerosis.
7
Although the risks and complications associated with angiog-
raphy depends on the patient’s condition, operator’s skill, and
judgment, any invasive procedure has some complications asso-
ciated with the procedure.5 Coronary angiography can be ac-
cessed via the potential arteries included brachial, radial and
femoral arteries.7–11 About 95% of angiography is performed
via femoral artery.12,13
Access to the heart via femoral artery can be accompanied with
complications such as arrhythmia, vascular complications
(bleeding, hematoma, and thrombosis), injury and myocardial
ischemia, coronaryartery perforation, hemodynamic collapse,
cer-
ebrovertebral accident including transient ischemic attack,
allergy
to contrast media and acute renal failure.14–18 Demonstration
of
these complications can be divided in two main form of acute
and chronic. The former includes hematoma, bleeding,
thrombosis, urinary retention, low back pain, and groin pain.5
Studies have shown that to avoid possible complications due
to arterial injuries, the current method of treatment after
Delta:1_given name
Delta:1_surname
Delta:1_given name
Delta:1_surname
Delta:1_given name
mailto:[email protected]
http://dx.doi.org/10.1016/j.jvn.2016.05.001
22. http://crossmark.crossref.org/dialog/?doi=10.1016/j.jvn.2016.05
.001&domain=pdf
http://dx.doi.org/10.1016/j.jvn.2016.05.001
http://dx.doi.org/10.1016/j.jvn.2016.05.001
http://www.jvascnurs.net
Vol. XXXIV No. 3 JOURNAL OF VASCULAR NURSING
PAGE 107
www.jvascnurs.net
angiography in many health care facilities in Iran is to have the
patient rest in the supine position with the head angle of zero
de-
grees for 8–24 hours and keeping 4 kg (8.82 lbs) sandbag on the
catheter insertion site for 6 hours,19–21 which has often been
conducted based on tradition and experience.19 This insistence
on bed rest for patients after coronary catheterization can lead
to restlessness, discomfort, and frequent complaint of back and
groin pain.
11
About 42% of patients who get out of bed after
4 hours of rest experience back pain.24 In addition, 11.4% of
pa-
tients undergoing this procedure may develop urinary reten-
tion.14,25 Back pain, groin pain, and urinary retention leads to
the use of analgesic medications and urinary catheterization
which are associated with their own specific complications. To
avoid complications resulting from the use of analgesic
medications and urinary catheterization, nonmedical measures
and nursing care are appropriate.10
Development of technology along with procedures requires
appropriate medical and nursing care.
23. 22,23
Although there is
much evidence for medical approach to care, little evidence
exists to support the suggestions relating to management areas
such as patient’s position, the time of getting out of bed, and
the time of removing sandbag which are generally related to
the nursing activities territory.9,24-26 A recent literature
review
showed that caring of patients undergoing cardiac
catheterization requires a revision in key areas of nursing
care.19,22,25 Abdollahi et al14 (2013) reported that in addition
to
changes in body position and leaving the bed early, no vascular
complications in patients undergoing coronary angiography
was seen, whereas urinary retention in the control group was
observed. Rezaei-Adaryani et al
19
(2009) reported that patients
whose positions were switched during the period of bed rest
had experiences less fatigue but more comfort and satisfaction
in the 3, 6, 8, and 24 hours after arrival to the postangiography
ward. In addition, changes in body position had no significant
impact on increased bleeding and hematoma compared with
the control group.19 Heravi et al27 (2013) comparing the
patients
in supine positions with the head angle of 0, 15, 30, 45, and 60
in
separate groups reported that patients with head angle of 45�
had
experienced the lowest pain, so it was declared as the best
position.
One of the nursing measures is changing the position of the
24. patient who has undergone transfemoral angiography during
bed rest, but it is avoided due to the fear of the vascular
complications.
The effects of position change in patients after transfemoral
angiography during bed rest will be evaluated as it relates to
vascular complications. This study aimed to determine the ef-
fect of changing position on urinary retention, back pain, pain
in the groin, and comfort of patients undergoing coronary
angiography.
METHOD
The study is a single-blind randomized clinical trial in two
groups which was approved by the Kurdistan University of
Medical Sciences research Council. The study’s proposal is
registered at (www.irct.com) by the registration number
IRCT2015091424018N1.
Sample size and sampling
The samples were chosen by convenience sampling method,
and they were randomly allocated into control and intervention
groups. The sample size with 95% confidence interval and
80% statistical power was estimated 60 patients (30 patients in
the intervention group and 30 patients in the control group)
(Figure 1).
Participants
Participants were patients undergoing coronary angiography.
Inclusion criteria included nonemergency catheterization, age
18–65 years old, less than 180/100 mm Hg blood pressure,
absence of active bleeding disorders, prothrombin time (PT),
and partial thromboplastin time (PTT) of less than 16 and 90
sec-
onds, respectively, consent to participate in the study, angiog-
raphy via the femoral artery, no history of deep vein
25. thrombosis (DVT) before the procedure, not being treated with
thrombolytic (not taking streptokinase) and anticoagulant drugs
(not taking warfarin), no history of diabetes with sensory prob-
lems, not taking any analgesic medications before the
procedure,
not suffering from peripheral arterial disease, no history of uri-
nary problems, no history of allergy to contrast media, no
depen-
dency to drugs, lack of chronic low back pain, absence of blood
and liver diseases. Exclusion criteria included needle entrance
more than once to access the artery, cardiopulmonary resuscita-
tion during angiography, movement disability, and disorder in
the level of consciousness in a way that the patient can not
coop-
erate to change position and incomplete termination of clinical
intervention period.
Ethical considerations
This study was approved by the Research Council of Kurdi-
stan University of Medical Sciences with the contract number
1035/31229/14 and was confirmed for ethical considerations by
receiving the moral code muk.rec.1394.194 from the ethics
com-
mittee of Kurdistan University. While explaining the purpose
and
method of study for the patients, informed consent was obtained
from them.
Measuring tool
The instrument used to collect and record information in this
was a three-part questionnaire which was designed according to
the study.
The first part was demographic and clinical information form
26. which contained information about age, height, weight, gender,
marital status, education, occupation, history of smoking, dia-
betes, history of previous coronary angiography, systolic and
dia-
stolic blood pressure, body mass index, PT, PTT, international
normalized ratio, and platelet count which was recorded based
on the information contained in patients’ medical records.
Patients’ blood pressure was measured and recorded by one
person using a mercury sphygmomanometer (ALP K2 model:
no 300-VS; Tanaka Sangyo Co, Ltd, Tokyo, Japan) which was
calibrated before the start of the study. Their height and weight
were measured and recorded by one person using digital scales
(Bermend BD7750) and centimeters. The second section con-
tained procedural information form which contained the length
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Assessed for eligibility (n = 81)
Excluded (n= 15):
• Chronic Low Back Pain(n = 6)
• unwillingness to participate in
the study(n = 4)
• history of taking
anticoagulant(n = 2)
• Dependence on opium (n = 3)
Randomized (n = 66)
27. Allocated to intervention group(n = 33):
• Received routine care (n = 33)
• Did not received routine care (n = 0)
A
llo
ca
ti
on
E
nr
ol
lm
en
t
Allocated to control group (n = 33)
• Received changing of body
position(n = 33)
• Did not receive allocated
intervention(n = 0)
F
ol
lo
w
28. u
p
Lost to follow up (n =3):
• Had anaphylactic reactions to the
contrast agent(n =2)
• Failure to did angiography because
of obstruction in abdominal aortic
(n =1)
Lost to follow up (n =3):
• Had chest pain and take analgesic
medications (n=2)
• 3 times needle inserted to access
artery (n =1)
A
na
ly
si
s
Analyzed (n =30) Analyzed (n =30)
Figure 1. Consolidated Standards of Reporting Trials
(CONSORT) flow diagram.
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29. of angiography, homeostasis time, size of the catheter used,
injury of the femoral artery, and the type and volume of contrast
agent, diagnosis of coronary artery stenosis which were
prepared
using a chronometer and the information contained in patient
records.
Part three of the evaluation form included angiographic com-
plications such as hematoma, bleeding, urinary retention, back
pain, groin pain, and comfort. Back pain, groin pain, and
comfort
were measured and recorded with standard numeric rating
scale.28 Patients’ comfort level was measured by a general
ques-
tion about the overall level of comfort at the time of measure-
ment. The patients were asked to rate their comfort from 0 to
10 grades. The validity of this scale was set by Johnson and
Carol.22 The reliability was estimated by Farrar et al and Good
et al to be 0.78 and 0.83.29,30 Hematoma shape and bruise was
placed on transparent paper and then on graph paper, and the
side of intended shape was measured and recorded (based on
the biggest length and width) per square centimeter. The
amount of bleeding was measured by weighing Gauze soaked
in blood by 0.1 gm sensitive Japanese scale (standard future).
Urinary retention was also analyzed based on patient interview.
All the measurements were carried out by the principal
researcher.
Intervention procedures
After the selection of eligible patients for inclusion into the
study and providing the necessary explanations, obtaining
informed consent, necessary data were obtained from medical
re-
cords, and blood pressure was measured and recorded. The pa-
tients were randomly entered into to the intervention group.
After controlling patients’ vital signs and marking dorsal pedis
30. and posterior tibialis pulses on their feet, the patients were
entered in the angiography catheterization room. On completion
of angiography and exiting the catheterization laboratory, the
sheath was removed by cardiology nurses, mechanical or manual
homeostasis was applied on the insertion site until the blood
coagulated. The time hemostasis was measured by stopwatch,
and it procedural information was recorded based on the case.
After hemostasis, 2 folded 4 � 4 (4 cm length and width)
gauzes was put on the catheter site (the reason of making the
gauzes 2 folded was to expose the catheter insertion site to the
maximum extent possible for ease of evaluating complications).
Transparent bandage covered the dressing to check for the ease
in
monitoring for hematoma and bleeding. Then, two 4 kg (8.82
lbs)
sandbags were placed on the site, and the second sandbag was
removed after stabilization of the patient. The patient came to
the postangiography ward with only one sandbag. After entering
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TABLE 1
PROTOCOLS OF BODY POSITION AND METHODS OF
ANALYSIS IN THE GROUPS
Group 1st & 2nd hour 3rd & 4th hour 5th hour 6th hour 7th &
8th hour 9th hour 24th hour
Intervention
Group
31. Supine Supine, HOB Right side, HOB Left side, HOB Sitting
position OOB OOB
45� El 15� El 15� El
Control group Supine Supine Supine Supine Supine OOB OOB
HOB = head of bed; EL = elevation.
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the control group patients to the postangiography ward routine,
cares were performed. The patient was immobile in the supine
position, with head angle of zero degree, 8 hours complete bed
rest, and 4 kg (8.2 lbs) sandbags was put on the site where the
catheter was inserted for 6 hours.
After entering the intervention group patients to the post
angiography ward, the patient had 8 hours complete bed rest,
4 kg sandbag was put on the site where the catheter was inserted
for 6 hours, but changing position was applied while taking rest
in the bed for 8 hours (Table 1). During the first and second
hours,
the patient was kept in the supine position and the head angle of
zero degree. During the third and fourth hours, the patient was
kept in the supine position with the head angle of 45�. During
the fifth and sixth hours, the patient was lying on the left or
right
side with the head angle of 15� and in the seventh and eighth
hour
the patients were cared in the sitting position (Table 2). The
third
part of the questionnaire was measured and recorded immedi-
ately after entering the ward, third, sixth, eighth, and 24th hours
later (before discharge from the ward; Table 2).
32. Statistics
After collecting data to assess the normal distribution of data,
Kolmogorov–Smirnov test was used. To compare the two inter-
vention and control groups in terms of demographic, clinical,
and procedural quality, chi-square and Fisher’s exact tests were
used. Moreover, to compare quantitative variables independent
t-test and Mann–Whitney tests were used.
RESULTS
Eighty-one patients were assessed for inclusion criteria.
Some patients were excluded from the study for the following
reasons including; three patients because of a history of chronic
low back pain, four patients because of an unwillingness to
participate in the study, two patients because of the history of
anticoagulant, and three patients due to taking opium. Thirty-
three patients were assigned to each group. During the study,
in the intervention group, two patients were excluded from the
study due to chest pain and taking analgesic and one patient
due to needle entrance to the arteries more than once. In the
con-
trol group, two patients were excluded due to anaphylactic reac-
tions and one patient due to stenosis in the abdominal aorta.
Finally, two groups (n = 30, each group) were analyzed. There
was no significant difference between the two groups of
participants in terms of demographic and clinical data include
of mean age, height, weight, systolic blood pressure, diastolic
blood pressure, body mass index, PT, PTT, platelet count, inter-
national normalized ratio, homeostasis time length, contrast me-
dia volume, amount of smoking, marital status, education level,
smoking history, history of diabetes, history of previous
coronary
angiography, rupture of the femoral artery, final diagnosis,
recommend treatment, and the amount of stenosis in the right
coronary, left main coronary, left circumflex arteries, and the
33. two groups were homogenous (Tables 3 and 4). But in terms of
gender, occupation, catheter size, type of contrast, the stenosis
of left anterior descending artery, and duration of angiography
were significantly different (Tables 3 and 4). The mean age of
the patients was 10.445 � 57.71, and 34 patients (56.66%)
were male and 58 (96.65%) were married.
The results showed that the incidence of hematoma between
the two groups was not significant. Moreover, hematoma in the
intervention group (P = 0.006) was significantly different at
different times, but in the control group (P = 0.149), the differ-
ence was not significant (Table 4).
Considering the P values in Table 5, to compare between
intervention and control groups at different times, there were
no significant differences between the intervention and control
groups in terms of hematoma (Table 5).
The results showed that the incidence of urinary retention in
the control group (P = 0.023) and intervention group (P = 0.020)
were significantly different at different times (Table 4). With
re-
gard to the P values in Table 5, pairwise comparison between
intervention and control group at different times, there were no
significant differences between the intervention and control
groups in terms of complications of urinary retention (Table 4).
Furthermore, the incidence of thrombosis remained un-
changed at different times and was not observed in none of the
participants.
In addition, the incidence of bleeding was significantly
different in terms of time (P $ 0.001). The test results of
Bonfer-
roni procedure showed that in the control group at third, eighth,
and 24th hours were not significantly different in terms of the
34. mean of this variable and in the intervention group there was a
significant difference only between the time of entrance and
the other times.
The results showed that the incidence of bruise between the
two groups in different measurements did not differ
significantly
in terms of time (P = 0.081).
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TABLE 2
DISTRIBUTION OF UNITS IN TERMS OF VARIABLES
Variable Group Mean � SD P value
Age* Control 56.56 � 9.15 0.401
Intervention 58.86 � 11.74
Heighty Control 164.16 � 11.31 0.151
Intervention 166.16 � 12.58
Weight* Control 74.88 � 21.67 0.52
Intervention 77.43 � 22.64
The number of cigarettes smoked per
dayy
Control 8.1 � 4.1 0.076
Intervention 9.15 � 56.56
No. of previous angiographyy Control 0.66 � 0.33 0.076
35. Intervention 16.36 � 0.1
Systolic blood pressurey Control 122.26 � 19.11 0.653
Intervention 123.33 � 14.93
Diastolic blood pressure
y
Control 74.03 � 11.58 0.583
Intervention 75.33 � 8.6
Volume of contrast dyey Control 51.33 � 23 0.564
Intervention 51.33 � 22.55
BMI
y
Control 55.99 � 36.64 0.6
Intervention 26.34 � 3.62
PTy Control 11.73 � 0.86 0.364
Intervention 11.56 � 0.93
PTT
y
Control 31.7 � 3.00 0.298
Intervention 33.1 � 6.7
Plt count* Control 245230 � 9.15 0.298
Intervention 250610 � 80.01
INRy Control 17 � 1.15 0.292
Intervention 1.14 � 0.28
Duration of hemostasis periody Control 7.95 � 3.69 0.603
36. Intervention 6.41 � 1.67
Duration of angiography periody Control 23.78 � 10.51 0.031
Intervention 245230 � 9.15
BMI = body mass index; INR = international normalize rate; PT
= protrombin time; Plt count = platelet count; PTT = partial
thromboplastin time.
*T independent.
yMann–Whitney.
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The results showed that the incidence of groin pain was
significantly different in terms of time (P > 0.001). The results
of Bonferroni for comparing sampling time between the inter-
vention and control groups showed that during the study period
except at zero and 24th hour the difference was significant in
terms of intended complication.
The results showed that the incidence of comfort (based on
numeric rating scale) had a significant difference in terms of
time in this complication (P = 0.001). Bonferroni procedure
for pairwise comparisons of the sampling time between the
intervention and control groups during the study period showed
a significant difference except for the time of admission and
24th hour. Moreover, there was a significant difference for the
incidence of back pain in terms of time. Bonferroni for pairwise
comparisons of the sampling time between the intervention and
control groups during the study period showed a significant dif-
ference in terms of comfort except for the time of entrance and
24th hour.
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TABLE 3
DISTRIBUTION OF SUBJECTS BASED ON QUALITATIVE
VARIABLES BETWEEN THE TWO GROUPS OF
CONTROL AND INTERVENTION
Variable Subgroup Intervention Control P value
Gender** Male 22 12 0.009
Female 8 18
Marital status** Married 30 28 0.492
Single 0 1
Widow 0 1
Divorced 0 0
Education** Illiterate 22 18 0.445
Under diploma 7 9
Diploma 1 3
Academic 0 0
Job status** Clerk 2 1 0.002
Self-employed 19 6
38. Retired 3 4
Housewife 6 18
Unemployed 0 1
Smoking history* Has 17 8 0.018
Has not 13 22
Diabetes record* Has 7 9 0.559
Has not 23 21
Angiography
history**
Has 1 6 0.103
Has not 29 24
Catheter size** F400 1 0 0.006
F500 1 0
F600 20 29
F700 8 1
Rupture of the
femoral artery**
Has 0 0 1.00
Has not 30 30
Type of contrast
media**
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TABLE 3
CONTINUED
Variable Subgroup Intervention Control P value
Urinary
retention***
Has 9 10
Has not 21 20
F00 = French; NECA = normal epicardial coronary arteries;
1VD = one vessel disease; 2VD = two vessel disease; 3VD =
three vessel disease; RCA = right
coronary artery; LMCA = left main coronary artery; LCX = left
circumflex artery; LAD = left anterior descending.
Chi-square test**, Fisher exact test*, and Friedman test*.
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DISCUSSION
The findings of this study showed that changes in body posi-
tion after angiography did not create a change in the incidence
of
vascular complications including hematoma, bleeding, throm-
bosis, and bruising compared to the control group, whereas uri-
nary retention was reduced. In addition, changing body
41. position reduced back pain, groin pain, and finally improved
the comfort of the patient.
Other studies finding agree with the results of this study and a
significant difference in the incidence of complications after
cor-
onary angiography at the catheter insertion site between the
inter-
vention and control groups was not reported. For example,
TABLE 4
RESULTS OF ACUTE COMPLICATIONS
Variable Group Hour 0 Hour 3rd
Hematoma* Control 1.07 � 3.23 1.07 � 3.23
Intervention 0.43 � 2.19 0.43 � 2.19
Urinary retention* Control 2 1.93 � 0.25
Intervention 1.93 � 0.25 2.56 � 3.68
Bruise
y
Control 1.08 � 3.37 1.1 � 3.37
Intervention 0.35 � 1.82 0.36 � 1.82
Bleeding
y
Control 0 0.01 � 0.07
Intervention 0 0.01 � 0.05
Back painy Control 2.74 � 2 3.1 � 4.46
Intervention 2.66 � 1.6 3.3 � 2.83
42. Groin painy Control 0.26 � 0.63 3.1 � 2.57
Intervention 0 1.03 � 2.04
Comforty Control 9.66 � 1.82 7.6 � 2.48
Intervention 10 9.06 � 1.7
Thrombosisy Control 0 0
Intervention 0 0
*Friedman test.
yRepeated measures test.
Abdollahi et al (2015) studied the simultaneous effects of early
ambulation (4 hours of bed rest) and changes in body position
with a different protocol from this study. The time points for
analyzing the patient in terms of complications were different.
In their study, no hemorrhage and hematoma was reported. It
was found that changes in body position in and early ambulation
after coronary interventions did not increase the vascular
complications.14
Furthermore, the results indicated that changes in body posi-
tion had no impact on the incidence of acute vascular complica-
tions, including hematoma and bleeding. Moreover, Yeganeh
Khah et al (2012) compared the effect of different ways of
chang-
ing patients’ position on the vascular complications of after
Hour 6th Hour 8th Hour 24th Sig
0.61 � 1.78 0.31 � 0.97 0.08 � 0.43 0.006
0.33 � 1.64 0.1 � 0.40 0 0.149
1.83 � 0.37 1.76 � 0.43 1.8 � 0.4 0.023
1.8 � 0.4 1.7 � 0.46 1.9 � 0.25 0.02
1.03 � 3.18 0.8 � 2.54 0.12 � 0.45 0.081
0.16 � 0.73 0.026 � 0.14 0.026 � 0.14
2.3 � 12.77 0.16 � 0.54 4.38 � 7.56 0.001>
43. 0.01 � 0.03 0.11 � 0.19 5.34 � 4.59
3.14 � 5.8 3.26 � 4.03 1.85 � 0.43 0.001>
3.14 � 2.3 2.75 � 1.56 0
4.86 � 3.08 3.7 � 2.74 2.36 � 2.20 0.001>
1.96 � 2.37 1.86 � 2.16 1.66 � 2.45
6.03 � 2.2 6.6 � 2.4 8.63 � 1.67 0.001>
8.5 � 2.2 7.9 � 2.39 8.9 � 2.15
0 0 0 0
0 0 0 0
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TABLE 5
MANN–WHITNEY TEST TO COMPARE THE
GROUPS TWO BY TWO IN TERMS OF STUDY
TIME
Variable Measurement time P value
Hematoma Entrance time 0.317
Third hour 0.579
Sixth hour 0.394
Eighth hour 0.222
24th hour 0.222
44. Urinary retention Entrance time 0.312
Third hour 0.563
Sixth hour 0.741
Eighth hour 0.977
24th hour 0.154
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coronary angiography and reported that none of the patients
developed bleeding and …