March 19, 2020
Nonsedation or Light Sedation in Critically Ill, Mechanically Ventilated Patients.
What was the research question?
·Does a plan of no sedation in mechanically ventilated patients have an effect on mortality compared to a plan of light sedation?
How did they do it?
A multicenter, non-blinded, randomized, controlled trial, with a 1:1 ratio assignment.
Control group: light sedation: RASS score -2 to -3
Intervention group: no sedation, PRN if needed.
The primary outcome was mortality at 90 days.
Secondary outcomes were the number of major thromboembolic events, the number of days free from coma or delirium, acute kidney injury according to severity, the number of ICU-free days, and the number of ventilator-free days.
What did they find?
90-day mortality was not different between non-sedation group and light sedation group (42.4% vs. 37.0%, P=0.65).
No significant difference in the days until death (13 vs. 12), number of ICU-free days (13 vs. 14), ventilator-free days (20 vs. 19), highest RIFLE score (2 vs. 2), days free from coma or delirium (27 vs. 26), and accidental extubation requiring reintubation in the first 1 hour (1.1% vs. 0.3%) between the two groups.
Higher rate of major thromboembolic events occurred in sedation group (2.8%) compared to 0.3% in the non-sedation group.
Higher rate of accidental extubation requiring reintubation <24 hours occurred in the non-sedation group (8.9%) compared to 4% in the sedation group (p=0.01).
Higher rate of accidental removal of other equipment (NGT, art line) in the non-sedation group (15%) compared to 9% in the sedation group (p= 0.01).
Confidence intervals was not adjusted for multiple comparisons, therefore, cannot infer treatment effects.
Cross over rate was 27% of no sedation patients to receive sedation during the first 24hours after randomization
RASS score differed by only 1 on day 1 (-1.3 vs -2.3) and 7 (-1.8 vs 2.8), too little to test the hypothesis.
14% of patients declined and [potential for selection bias.
1:1 nursing ratio, cannot be generalized.
What does it mean?
No significant difference in 90-day mortality with the use of no sedation compared to light sedation strategies. Less cases of major embolic events but more accidental extubations and removal of other equipment.
The study supports the practice to continue targeting light sedation (ie RASS -2 to 1) combined with daily sedation interruptions.