Approaches to removal of sedation and mechanical ventilation for critically ill patients
vary widely. Our aim was to assess a protocol that paired spontaneous awakening trials
(SATs)-ie, daily interruption of sedatives-with spontaneous breathing trials (SBTs).
In four tertiary-care hospitals, we randomly assigned 336 mechanically ventilated
patients in intensive care to management with a daily SAT followed by an SBT (intervention
group; n=168) or with sedation per usual care plus a daily SBT (control group; n=168).
The primary endpoint was time breathing without assistance. Data were analysed by
intention to treat. This study is registered with ClinicalTrials.gov, number NCT00097630.
One patient in the intervention group did not begin their assigned treatment protocol
because of withdrawal of consent and thus was excluded from analyses and lost to follow-up.
Seven patients in the control group discontinued their assigned protocol, and two
of these patients were lost to follow-up. Patients in the intervention group spent
more days breathing without assistance during the 28-day study period than did those
in the control group (14.7 days vs 11.6 days; mean difference 3.1 days, 95% CI 0.7
to 5.6; p=0.02) and were discharged from intensive care (median time in intensive
care 9.1 days vs 12.9 days; p=0.01) and the hospital earlier (median time in the hospital
14.9 days vs 19.2 days; p=0.04). More patients in the intervention group self-extubated
than in the control group (16 patients vs six patients; 6.0% difference, 95% CI 0.6%
to 11.8%; p=0.03), but the number of patients who required reintubation after self-extubation
was similar (five patients vs three patients; 1.2% difference, 95% CI -5.2% to 2.5%;
p=0.47), as were total reintubation rates (13.8%vs 12.5%; 1.3% difference, 95% CI
-8.6% to 6.1%; p=0.73). At any instant during the year after enrolment, patients in
the intervention group were less likely to die than were patients in the control group
(HR 0.68, 95% CI 0.50 to 0.92; p=0.01). For every seven patients treated with the
intervention, one life was saved (number needed to treat was 7.4, 95% CI 4.2 to 35.5).
Our results suggest that a wake up and breathe protocol that pairs daily spontaneous
awakening trials (ie, interruption of sedatives) with daily spontaneous breathing
trials results in better outcomes for mechanically ventilated patients in intensive
care than current standard approaches and should become routine practice.