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pharma report




                                                                                                                                                                                        Korrekturexemplar
                                                    Post-intubation pulmonary complications (PIPC)

                                                    Taper-shaped cuff – a new approach in reducing
                                                    microaspiration
                                                    Although the problem of microaspiration during intubation has been known for years, it is still an
                                                    issue leading to pulmonary complications, including postoperative pneumonia and ventilator-
                                                    associated pneumonia (VAP). Taper-shaped cuffs which can provide a better sealing and thus ­better
                                                    protection against microaspiration constitute a new approach. Research has shown that a new
                                                    ­tapered design significantly reduces the leakage past the endotracheal tube cuff, limiting passage
                                                     of foreign material into the airways and lungs. The advanced-designed tube may help reduce the
                                                     risk of post-intubation pulmonary complications (PIPC).
Imprint
Taper-shaped cuff – a new approach
in reducing microaspiration                         Post-operative pulmonary com-
                                                                                            Fig. 1  Mortality and pneumonia rates with and without evidence of
Literature and Interview                            plications (PPC) occur common-
                                                                                            microaspiration
                                                    ly and are a major cause of over-
Author:
Dr. Katrina Recker, Hamburg                         all perioperative morbidity and                             Patients without evidence of microaspiration
                                                    mortality, prolonged hospital stay,                         Patients with evidence of microaspiration
Corporate Publishing (responsible):                 and increased cost of care [1]. Ac-                    50
Ulrike Hafner,
                                                    cording to Fleischmann et al., the                                                                                40.0
Dr. Katharina Finis, Dr. Friederike Holthausen,                                                            40
Sabine Jost, Dr. Claudia Krekeler,                  incidence of pulmonary compli-
                                                                                            Patients (%)




Inge Kunzenbacher, Dr. Sabine Lohrengel,            cations (2.7%) was highly compa-                       30
Dr. Annemarie Musch, Dr. Monika Prinoth,            rable to that of cardiac complica-                                            19.2
Katrin Schader, Dr. Petra Stawinski,                                                                       20
                                                    tions (2.5%) [2]. The definition of
François Werner, Teresa Windelen                                                                                                                               12.0
                                                    PPC includes pneumonia, respira-                       10
Translated reprint of a                             tory failure, atelectasis, broncho-                                   1.7
report in „Der Anaesthesist“                                                                                0
                                                    spasm, and exacerbation of chron-                                      Mortality                           Pneumonia
Volume 60, Issue 6, June 2011
                                                    ic obstructive pulmonary disease
                                                                                            modified from [6]
This publication is supported by                    (COPD) as well as post-intubation
Covidien Deutschland GmbH                           pulmonary complications (PIPC)
                                                    as the intubation-related sub-         lated parameters [1]. The closer                     12% in patients without such evi-
COVIDIEN, COVIDIEN with logo, Covidien logo
and positive results for life are U.S. and inter-   group of PPC.                          the incision is to the diaphragm,                    dence of microaspiration (p<0.01)
nationally registered trademarks of Covidien            PIPC encompass a broad range       the greater the risk for pulmonary                   (Fig. 1). Morbidity was increased
AG. Other brands are trademarks of a Covidien
                                                    of potential clinical outcomes –       complications. Aortic, thoracic, and                 in association with postopera-
company.
                                                    from mild and limited symptoms         abdominal procedures carry the                       tive pneumonia because length of
The editors of the journal assume no                as sore throat to severe diseas-       highest risk, followed by ­upper                     stay in the surgical intensive care
liability for the content of this column.           es such as respiratory failure and     ­abdominal surgery (e. g., cholecys-                 unit (6.2 vs 2.6 days), days intu-
                                                    ventilator-associated pneumo-           tectomy).                                           bated (2.7 vs 0.6), total postopera-
Springer Medizin
Springer-Verlag GmbH                                nia (VAP). VAP, defined as pneu-            The main cause for develop-                     tive days (15.3 vs 8.4), and mortali-
Tiergartenstraße 17                                 monia occurring more than 48            ment of ventilator-associated                       ty rates (19.2% vs 1.7%) were great-
69121 Heidelberg                                    hours after induction of mechan-        pneumonia is not the mechanical                     er than in patients without pneu-
                                                    ical ventilation, is the most com-      ventilation itself but the leakage                  monia [6].
Springer is part of
Springer Science+Business Media                     mon nosocomial infection in in-         past the endotracheal tube cuff
                                                    tensive care medicine and associ-       allowing pathogens to pass along                    Innovative shaped cuff for
© Springer-Verlag GmbH 2011                         ated with prolonged intensive care      the tube towards the lungs. This                    better sealing
Some commercial names, trade names and
                                                    and hospital stay as well as a high-    so called microaspiration can re-                   For decades, it has been assumed
trademarks etc. used in this text are designated    er mortality [3]. The mortality rate    sult in severe post-intubation pul-                 that endotracheal tubes (ETTs)
as such. However, neither the presence nor          for VAP ranges from 24% to 50%          monary complications. Microaspi-                    prevent aspiration. However, stud-
absence of such designation means that these
names should not be regarded in accordance          and is even higher (76%) in specif-     ration due to channels on the sur-                  ies have demonstrated that cur-
with the copyright and trademark laws or that       ic settings or when the infection is    face of cuffs has been verified both                rent barrel-shaped high-volume
they are for general use. Product liability: The    caused by high-risk pathogens [4].      in vitro and in vivo [5]. A study                   low-pressure (Hi-Lo) cuffs allow
printers and publishers cannot be held liable
for information on dosage and methods of                                                    published by Ephgrave et al. found                  aspiration of fluids through chan-
application. Information of this nature should      Microaspiration important               colonization of sputum with gas-                    nels formed in the cuff [7]. This
be reviewed for accuracy in each case by the
reader, using other sources of reference.
                                                    risk factor                             tric pathogens in 28% of postop-                    leakage around the endotrache-
                                                    Risk factors for popstoperative         erative patients [6]. These patients                al tube cuff is known to be one of
                                                    pulmonary complications include         had a 40% incidence of postoper-                    the major causes of microaspira-
                                                    advanced age and procedure-re-          ative pneumonia compared with                       tion [8].
pharma report
Korrekturexemplar

                          To address this problem, the                                                                                        shaped cuff. The new tube pro-
                                                              Fig. 2  Design of the endotracheal tube with a taper-shaped cuff
                    Mallinckrodt™ TaperGuard endo­                                                                                            vided significant microaspiration
                    tracheal tube was developed, in-                                        Oropharynx                                        protection compared to the con­
                    corporating a unique, taper-                                                                                              ventional tube in the categories
                    shaped cuff made from polyvinyl-                                                        Tracheal wall                     “dye leak“ and “bronchitis” (p<0.05
                    chloride (PVC) that is designed to                                                       Cuff creases
                                                                                                                                              ­resp. p<0.016).
                    substantially reduce the risk of
                    ­microaspiration. The cuff has a
                                                                             Sealing band
                     proximal end diameter larger than
                     the average adult trachea, taper-
                     ing to a smaller diameter at the
                     distal end (Fig. 2). By providing a                                                                                      References
                     more effective fluid seal, the taper-
                                                                                                                                              [1]	 Smetana GW, Cleve Clin J Med 2009;
                     shaped device reduces the risk of                                                                                              76 Suppl 4:S60–65
                     microaspiration among intubated                                          Lungs
                                                                                                                                              [2]	 Fleischmann KE et al., Am J Med
                     patients compared to the current         modified from Covidien                                                                2003; 115: 515–520
                     ­Hi-Lo™ ETT.                                                                                                             [3]	 Perl T, Quintel M, Anaesthesist 2011;
                                                                                                                                                    60: 236–242
                          This has been demonstrated in      sure (PEEP) to maintain lung vol-        and tube. None of the 31 patients       [4]	 Chastre J et al., Am J Respir Crit Care
                      a study with 63 morbidly obese pa-     ume during surgery. At the end           intubated with the taper-shaped               Med 2002; 165: 867–903
                      tients (body mass index {BMI} >40)     of laparoscopy, water containing         cuff endotracheal tube had any          [5]	 Van Aken H et al. Intensivmedizin.
                      undergoing the Roux-en-Y gastric       methylene blue was injected in the       evidence of microaspiration com-             2nd edition 2007: 106–108
                                                                                                                                              [6]	 Ephgrave KS et al., Surgery 1993; 114:
                      bypass procedure [9]. 31 patients      gastric pouch. The water flowed          pared to 13 of 32 patients intubat-
                                                                                                                                                    815–819
                      were randomly selected for intu-       back in the oral cavity, and dripped     ed with the conventional, barrel-       [7]	 Oikkonen M et al., Anaesthesia 52
                      bation with the new endotrache-        out of the mouth. Afterwards, the        shaped Hi-Lo tube.                            1997: 567–569
                      al tube and 32 participants were       tracheal tube was inspected above            These findings were corrobo-        [8]	 Rawlinson E et al., Anaesth Intensive
                      intubated with a conventional en-      and below the cuff by bronchosco-        rated by the results of an animal             Care 2007; 8: 365–867
                                                                                                                                              [9]	 Van den Brande F et al., Eur J Anaes-
                      dotracheal tube using a Hi-Lo cuff.    py. The leak test was positive when      model of aspiration [10]. Four-               thesiol 2010; 27: 250
                      The patients were ventilated with      methylene blue was visualized be-        teen pigs were intubated with           [10]	 Lichtenthal P et al., Crit Care 2010; 14
                      5cm positive end-expiratory pres-      low the cuff between tracheal wall       either the Hi-Lo-ETT, or the taper-           Suppl 1: P229




                     Different approaches to reduce the risk of microaspiration
                     Interview with Prof. Michael Quintel, Department of Anaesthesia at Centre of Anaesthesia, Emergency Medicine and Intensive Care,
                     University of Göttingen

                                             Could you please explain the role of microaspiration      How can microaspiration during surgery be prevented?
                                             for the development of post-intubation pulmonary          Quintel: There are different approaches to reduce the risk of microaspira-
                                             complications (PIPC)?                                    tion. One would certainly be the reduction of colonization of pathogens
                                             Quintel: The main risk associated with intubation        in the oropharynx by either using teeth brushing as a procedure which
                                             is microaspiration during in- and extubation.            can be performed by the patient. One may also use substances like clo-
                                             There have been studies performed showing                rhexidine for cleaning of the oropharynx immediately prior to intubation
                                             that teeth brushing reduces the bacterial con-           which would also reduce the contamination of the oropharynx.
                                             tamination of the oropharynx and thus leads to           	 In addition, three key issues concerning the endotracheal tube
                     a marked reduction of pulmonary complication after large intrathorac-            should be taken into consideration: 1) Supraglottic suctioning during the
                     ic procedures. This may be seen as evidence that microaspiration plays           procedure might reduce the amount of fluid above the cuff which has
                     an important role in the perioperative period and in the postoperative           to be retained by the cuff. 2) Continuous control of the cuff pressure is
                     intensive care setting.                                                          ­important to allow the reduction of any pressure damage to the trachea.
                                                                                                       3) The optimal inflation can avoid any kind of rinsing along the endotra-
                     Why is microaspiration still a problem in the operating room?                     cheal tube.
                     Quintel: For a long time, peri- and postoperative pulmonary complica-
                     tions have been regarded as almost inevitable and microaspiration as             Why can it be useful to drain secretions which pool above the cuff with a
                     a possible cause was underestimated. Today, there are more and more              subglottic drainage?
                     hints from the literature that microaspiration especially during large sur-      Quintel: This is because drainage reduces the amount of fluid which po-
                     gical procedures might influence the outcome of the patients.                    tentially contains bacterial load and might rinse along the endotracheal
                     	 Increase in knowledge as well as new devices like the endotracheal             tube or along the cuff down the trachea. While using mechanical ventila-
                     tube featuring a taper-shaped cuff created a growing awareness of post-          tion, this fluid can spread down to the deeper parts of the lungs just by
                     operative pulmonary problems among anaesthesists.                                the flow of the inspiration.

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Taper-shaped cuff reduces microaspiration

  • 1. pharma report Korrekturexemplar Post-intubation pulmonary complications (PIPC) Taper-shaped cuff – a new approach in reducing microaspiration Although the problem of microaspiration during intubation has been known for years, it is still an issue leading to pulmonary complications, including postoperative pneumonia and ventilator- associated pneumonia (VAP). Taper-shaped cuffs which can provide a better sealing and thus ­better protection against microaspiration constitute a new approach. Research has shown that a new ­tapered design significantly reduces the leakage past the endotracheal tube cuff, limiting passage of foreign material into the airways and lungs. The advanced-designed tube may help reduce the risk of post-intubation pulmonary complications (PIPC). Imprint Taper-shaped cuff – a new approach in reducing microaspiration Post-operative pulmonary com- Fig. 1  Mortality and pneumonia rates with and without evidence of Literature and Interview plications (PPC) occur common- microaspiration ly and are a major cause of over- Author: Dr. Katrina Recker, Hamburg all perioperative morbidity and Patients without evidence of microaspiration mortality, prolonged hospital stay, Patients with evidence of microaspiration Corporate Publishing (responsible): and increased cost of care [1]. Ac- 50 Ulrike Hafner, cording to Fleischmann et al., the 40.0 Dr. Katharina Finis, Dr. Friederike Holthausen, 40 Sabine Jost, Dr. Claudia Krekeler, incidence of pulmonary compli- Patients (%) Inge Kunzenbacher, Dr. Sabine Lohrengel, cations (2.7%) was highly compa- 30 Dr. Annemarie Musch, Dr. Monika Prinoth, rable to that of cardiac complica- 19.2 Katrin Schader, Dr. Petra Stawinski, 20 tions (2.5%) [2]. The definition of François Werner, Teresa Windelen 12.0 PPC includes pneumonia, respira- 10 Translated reprint of a tory failure, atelectasis, broncho- 1.7 report in „Der Anaesthesist“ 0 spasm, and exacerbation of chron- Mortality Pneumonia Volume 60, Issue 6, June 2011 ic obstructive pulmonary disease modified from [6] This publication is supported by (COPD) as well as post-intubation Covidien Deutschland GmbH pulmonary complications (PIPC) as the intubation-related sub- lated parameters [1]. The closer 12% in patients without such evi- COVIDIEN, COVIDIEN with logo, Covidien logo and positive results for life are U.S. and inter- group of PPC. the incision is to the diaphragm, dence of microaspiration (p<0.01) nationally registered trademarks of Covidien PIPC encompass a broad range the greater the risk for pulmonary (Fig. 1). Morbidity was increased AG. Other brands are trademarks of a Covidien of potential clinical outcomes – complications. Aortic, thoracic, and in association with postopera- company. from mild and limited symptoms abdominal procedures carry the tive pneumonia because length of The editors of the journal assume no as sore throat to severe diseas- highest risk, followed by ­upper stay in the surgical intensive care liability for the content of this column. es such as respiratory failure and ­abdominal surgery (e. g., cholecys- unit (6.2 vs 2.6 days), days intu- ventilator-associated pneumo- tectomy). bated (2.7 vs 0.6), total postopera- Springer Medizin Springer-Verlag GmbH nia (VAP). VAP, defined as pneu- The main cause for develop- tive days (15.3 vs 8.4), and mortali- Tiergartenstraße 17 monia occurring more than 48 ment of ventilator-associated ty rates (19.2% vs 1.7%) were great- 69121 Heidelberg hours after induction of mechan- pneumonia is not the mechanical er than in patients without pneu- ical ventilation, is the most com- ventilation itself but the leakage monia [6]. Springer is part of Springer Science+Business Media mon nosocomial infection in in- past the endotracheal tube cuff tensive care medicine and associ- allowing pathogens to pass along Innovative shaped cuff for © Springer-Verlag GmbH 2011 ated with prolonged intensive care the tube towards the lungs. This better sealing Some commercial names, trade names and and hospital stay as well as a high- so called microaspiration can re- For decades, it has been assumed trademarks etc. used in this text are designated er mortality [3]. The mortality rate sult in severe post-intubation pul- that endotracheal tubes (ETTs) as such. However, neither the presence nor for VAP ranges from 24% to 50% monary complications. Microaspi- prevent aspiration. However, stud- absence of such designation means that these names should not be regarded in accordance and is even higher (76%) in specif- ration due to channels on the sur- ies have demonstrated that cur- with the copyright and trademark laws or that ic settings or when the infection is face of cuffs has been verified both rent barrel-shaped high-volume they are for general use. Product liability: The caused by high-risk pathogens [4]. in vitro and in vivo [5]. A study low-pressure (Hi-Lo) cuffs allow printers and publishers cannot be held liable for information on dosage and methods of published by Ephgrave et al. found aspiration of fluids through chan- application. Information of this nature should Microaspiration important colonization of sputum with gas- nels formed in the cuff [7]. This be reviewed for accuracy in each case by the reader, using other sources of reference. risk factor tric pathogens in 28% of postop- leakage around the endotrache- Risk factors for popstoperative erative patients [6]. These patients al tube cuff is known to be one of pulmonary complications include had a 40% incidence of postoper- the major causes of microaspira- advanced age and procedure-re- ative pneumonia compared with tion [8].
  • 2. pharma report Korrekturexemplar To address this problem, the shaped cuff. The new tube pro- Fig. 2  Design of the endotracheal tube with a taper-shaped cuff Mallinckrodt™ TaperGuard endo­ vided significant microaspiration tracheal tube was developed, in- Oropharynx protection compared to the con­ corporating a unique, taper- ventional tube in the categories shaped cuff made from polyvinyl- Tracheal wall “dye leak“ and “bronchitis” (p<0.05 chloride (PVC) that is designed to Cuff creases ­resp. p<0.016). substantially reduce the risk of ­microaspiration. The cuff has a Sealing band proximal end diameter larger than the average adult trachea, taper- ing to a smaller diameter at the distal end (Fig. 2). By providing a References more effective fluid seal, the taper- [1] Smetana GW, Cleve Clin J Med 2009; shaped device reduces the risk of 76 Suppl 4:S60–65 microaspiration among intubated Lungs [2] Fleischmann KE et al., Am J Med patients compared to the current modified from Covidien 2003; 115: 515–520 ­Hi-Lo™ ETT. [3] Perl T, Quintel M, Anaesthesist 2011; 60: 236–242 This has been demonstrated in sure (PEEP) to maintain lung vol- and tube. None of the 31 patients [4] Chastre J et al., Am J Respir Crit Care a study with 63 morbidly obese pa- ume during surgery. At the end intubated with the taper-shaped Med 2002; 165: 867–903 tients (body mass index {BMI} >40) of laparoscopy, water containing cuff endotracheal tube had any [5] Van Aken H et al. Intensivmedizin. undergoing the Roux-en-Y gastric methylene blue was injected in the evidence of microaspiration com- 2nd edition 2007: 106–108 [6] Ephgrave KS et al., Surgery 1993; 114: bypass procedure [9]. 31 patients gastric pouch. The water flowed pared to 13 of 32 patients intubat- 815–819 were randomly selected for intu- back in the oral cavity, and dripped ed with the conventional, barrel- [7] Oikkonen M et al., Anaesthesia 52 bation with the new endotrache- out of the mouth. Afterwards, the shaped Hi-Lo tube. 1997: 567–569 al tube and 32 participants were tracheal tube was inspected above These findings were corrobo- [8] Rawlinson E et al., Anaesth Intensive intubated with a conventional en- and below the cuff by bronchosco- rated by the results of an animal Care 2007; 8: 365–867 [9] Van den Brande F et al., Eur J Anaes- dotracheal tube using a Hi-Lo cuff. py. The leak test was positive when model of aspiration [10]. Four- thesiol 2010; 27: 250 The patients were ventilated with methylene blue was visualized be- teen pigs were intubated with [10] Lichtenthal P et al., Crit Care 2010; 14 5cm positive end-expiratory pres- low the cuff between tracheal wall either the Hi-Lo-ETT, or the taper- Suppl 1: P229 Different approaches to reduce the risk of microaspiration Interview with Prof. Michael Quintel, Department of Anaesthesia at Centre of Anaesthesia, Emergency Medicine and Intensive Care, University of Göttingen Could you please explain the role of microaspiration How can microaspiration during surgery be prevented? for the development of post-intubation pulmonary Quintel: There are different approaches to reduce the risk of microaspira- complications (PIPC)? tion. One would certainly be the reduction of colonization of pathogens Quintel: The main risk associated with intubation in the oropharynx by either using teeth brushing as a procedure which is microaspiration during in- and extubation. can be performed by the patient. One may also use substances like clo- There have been studies performed showing rhexidine for cleaning of the oropharynx immediately prior to intubation that teeth brushing reduces the bacterial con- which would also reduce the contamination of the oropharynx. tamination of the oropharynx and thus leads to In addition, three key issues concerning the endotracheal tube a marked reduction of pulmonary complication after large intrathorac- should be taken into consideration: 1) Supraglottic suctioning during the ic procedures. This may be seen as evidence that microaspiration plays procedure might reduce the amount of fluid above the cuff which has an important role in the perioperative period and in the postoperative to be retained by the cuff. 2) Continuous control of the cuff pressure is intensive care setting. ­important to allow the reduction of any pressure damage to the trachea. 3) The optimal inflation can avoid any kind of rinsing along the endotra- Why is microaspiration still a problem in the operating room? cheal tube. Quintel: For a long time, peri- and postoperative pulmonary complica- tions have been regarded as almost inevitable and microaspiration as Why can it be useful to drain secretions which pool above the cuff with a a possible cause was underestimated. Today, there are more and more subglottic drainage? hints from the literature that microaspiration especially during large sur- Quintel: This is because drainage reduces the amount of fluid which po- gical procedures might influence the outcome of the patients. tentially contains bacterial load and might rinse along the endotracheal Increase in knowledge as well as new devices like the endotracheal tube or along the cuff down the trachea. While using mechanical ventila- tube featuring a taper-shaped cuff created a growing awareness of post- tion, this fluid can spread down to the deeper parts of the lungs just by operative pulmonary problems among anaesthesists. the flow of the inspiration.