A Protocol of No Sedation for Critically Ill Patients Receiving Mechanical Ventilation: a Randomised Trial

Thomas Strøm, Torben Martinussen, Palle Toft

Lancet 2010; 375 

Background: standard treatment of critically ill patients undergoing mechanical ventilation is continuous sedation. Daily interruption of sedation has a beneficial effect and in the general intensive care unit of Odense University Hospital, Denmark, standard practice is a protocol of no sedation. We aimed to establish whether duration of mechanical ventilation could be reduced with a protocol of no sedation versus daily interruption of sedation.

Methods: of 428 patients assessed for eligibility, we enrolled 140 critically ill adult patients who were undergoing mechanical ventilation and were expected to need ventilation for more than 24 h. Patients were randomly assigned in a 1:1 ratio (unblinded) to receive: no sedation (n=70 patients); or sedation (20 mg/mL propofol for 48 h, 1 mg/mL midazolam thereafter) with daily interruption until awake (n=70, control group). Both groups were treated with bolus doses of morphine (2·5 or 5 mg). The primary outcome was the number of days without mechanical ventilation in a 28-day period. The length of stay in the intensive care unit (from admission to 28 days) and in hospital (from admission to 90 days) were recorded. Analysis was by intention to treat. This study is registered with ClinicalTrials.gov, number NCT00466492.

Findings: 27 patients died or were successfully extubated within 48 h and, as per our study design, were excluded from the study and statistical analysis. Patients receiving no sedation had significantly more days without ventilation (n=55;mean 13·8 days, SD 11·0) than did those receiving interrupted sedation (n=58; mean 9·6 days, SD 10·0; mean difference 4·2 days, 95% CI 0·3–8·1; p=0·0191). No sedation was also associated with a shorter stay in the intensive care unit (HR 1·86, 95% CI 1·05–3·23; p=0·0316) and  in hospital for the first 30 days studied (3·57, 1·52–9·09; p=0·0039). No difference was recorded in the occurrences of accidental extubations, the need for CT or MRI brain scans, or ventilator-associated pneumonia. Agitated delirium was more frequent in the intervention group than in the control group (n=11, 20% vs n=4, 7%; p=0·0400).

Interpretation: no sedation of critically ill patients receiving mechanical ventilation is associated with an increase in ventilation free days. A multicentre study is needed to establish whether this effect can be reproduced in other facilities.

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