A presentation by Palle Toft at the 2017 meeting of the Scandinavian Society of Anaestesiology and Intensive Care Medicine. All available content from SSAI2017: https://scanfoam.org/ssai2017/ Delivered in collaboration between scanFOAM, SSAI & SFAI.

1. Palle Toft
Department of Intensive Care
Odense University Hospital
Denmark
Nonsedation – experimental or
routine ?
34th SSAI Congress ,malmö 2017.

2. Conflicts of interest:
None

3. Less is more
During the last 17 years a trend
towards less sedation

6. • Daily sedation interruption in mechanically ventilated
critically ill patients
• Cared for with a sedation protocol
• A RCT
• Metha et al ,JAMA 2012;308:1985-92
• Multicenterstudy (Canada and USA )
• Not blinded
• Intervention:
– Sedationsprotocol (RASS 0 til -3) and a daily wake-up trial
• Control
– Sedationprotocol (RASS 0 til -3)

8. Limitations
• Many ICU´s had a nurse to patient ratio of 1:1
• Many of the more complicated patients were excluded
• Only benzodiazepin, not propofol or dex.
• Broad sedationsscore RASS 0 til -3
• In ¾ of the patients a restraint was used
• In only 72% in the daily wake-up group a sedation
interruption was carried out.
• Larger doses of sedation and analgesia were given in the
daily wake-up group.

9. Mehtas take home message?
 If hourly scoring of sedation is used to limit the level of
sedation a daily wake-up trial might not improve
outcome further.
 PT´s take home message :Danger: oversedation

10. Wake up
And stay awake!

11. Number of ventilator free days
in a 28 days period

12. ICU length of stay (28 days)

13. Total hospital length of stay (90 days)

15. If a daily wake-up trial (sedation holliday )
is beneficial?
-why not prolong the holliday
 Continuous sedation holliday = The
NONSEDA Study

16. No sedation compared to sedation
with a daily wake-up trial.
A prospective randomized multicenter
study
The NONSEDA-study
 It is planned to include 700 patients in 8 centers in
Scandinavia

17. NONSEDA a RCT with 700 ICU pt’s
receiving mechanical ventilation
 Single center study
 non-sedation sedation
 Mortality ICU 22% 38%
 Mortality Hosp. 36% 47%
 700 pt’s need to be included when hospital mortality is
used for power calculation.

18. Primary goals for effect: Death within 90
days
 Secondary goals for effect:
 Death with observation periode
 Number of patients with tromboembolic events
 Number of patients with AKI
 Days alive outside the ICU
 Days alive without ventilator treatment
 Days alive outside hospital
 Explorative goals:
 Organfailure
 Coma free delirium free days

19. A priori defined subgroup
investigation in 200 pt´s
 1)Physical strength during and after ICU
 2)Cognitive function during and after ICU
 3)PTSD and neuropsychological investigation 3
months after ICU

20. Economy
• Supported by a large grant by the Danish
Council for Strategic Research
• Supported by Danielsen´s Foundation
• Supported by SSAI
• 95 % of budget (> 11mill D.kr.) has been
assigned

21. Change of culture
•Treat the patients according to the patients need, not the need
of the department
•Provide analgesics before sedatives
•Sedation is a “last way out”
•(Nurse to patient ratio 1:1)

22. Single center studies
 Homogenous treatment
 Local expertise
 Results might be difficult to extrapolate to other
hospitals
 (Tight BG regulation by Van den Berghe fx)

23. Multicenter studies
 Despite the presence of a common protocol,there is
often heterogeneity in treatment between different
centers
 The beneficial signal/result disappears
 A Hawthorne effect ?
 NONSEDA study: Only 8 centers, at least 20 patients
in each center
 It is a question of changing the culture in the ICU

24. NONSEDA scientific group

25. 0100200300400500600700
Patientsrandomized
01jan2014 01jan2015 01jan2016 31dec2016
Number included Number projected
NON-SEDA status September 2017

26. Patients randomized N
Kolding 205
Svendborg 39
Esbjerg 101
Århus 77
Odense 160
Tromsø 39
Tønsberg 54
Linkøbing 5
Total 680
Status NON-SEDA September 2017

27. Nonsedation in the ICU
• Nonsedation can be implemented
• Few adverse events –accidental extubation +
reintubation < 1 hour: 4 versus 1
• ICU patients have abnormal sleep (Yuliya
Boyko)
• Nonsedated patients have a tendency towards
less pressure ulcers ( Helene Korvenius N. )

28. Most patients with ARDS tolerate
Nonsedation

29. The danish
minister of health
about sedated ICU
patients:
Totally
unacceptable
Insane
Has to be stopped
immidiately
Oct 2016
(A sick culture )

30. Are you allowed
to sedate patients
without informed
consent ?
• A nonsedated patient is
transferred to a university
hospital for second opinion
• At arrival the patient is
immidiately sedated
• 24 hours later the patient is
returned to the home
hospital and sedation is
stopped
• The patient is again awake
and comfortable

31. They can
communicate

34. 34
Communication again

35. “Take home message”
•Treat the patients according to the patients need, not the need
of the department
•Provide analgesics before sedatives
•Sedation is a “last way out”
•In case of sedation use a sedation scale and perform daily
wake up trials
•Nonsedation can be implemented
•Nonsedation is not dangerous –Few Adverse events

36. Thank you for staying awake
The NONSEDA study
palle.toft@rsyd.dk