Efficacy and Safety of a Paired Sedation and Ventilator Weaning Protocol for Mechanically Ventilated Patients in Intensive Care (Awakening and Breathing Controlled trial): a Randomised Controlled Trial

Timothy D Girard, John P Kress, Barry D Fuchs, Jason W W Thomason, William D Schweickert, Brenda T Pun, Darren B Taichman, Jan G Dunn, Anne S Pohlman, Paul A Kinniry, James C Jackson, Angelo E Canonico, Richard W Light, Ayumi K Shintani, Jennifer L Thompson, Sharon M Gordon, Jesse B Hall, Robert S Dittus, Gordon R Bernard, E Wesley Ely

Lancet 2008; 371 

Background: 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).

Methods: 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.

Findings: 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 diff erence 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% diff erence, 95% CI 0·6% to 11·8%; p=0·03), but the number of patients who required reintubation after self-extubation was similar (fi ve patients vs three patients; 1·2% diff erence, 95% CI –5·2% to 2·5%; p=0·47), as were total reintubation rates (13·8% vs 12·5%; 1·3% diff erence, 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).

Interpretation 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.

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