A clinical approach to the prevention of excessive sedation in intensive care patients receiving invasive mechanical ventilation: the AWARE Study. Introduction of the study protocol

Abstract

Abstract

In the intensive care unit (ICU), mechanically ventilated patients receive sedation in order to control any discomfort, anxiety, and pain they may have, as well as to optimise the management of organ and especially respiratory failure. Several studies have shown the feasibility and the safety of strategies aiming to decrease sedation. These strategies have been associated with a significant reduction in the duration of invasive mechanical ventilation, without showing a reduction in mortality. Based on such a clinical approach to prevent excessive sedation, the AWARE study is proposing an algorithm to control excessive sedation by offering an alternative to the traditional sedation protocols with a gradual sedation in relation to the clinical situation with regular re-assessments of the exact needs using regular interruptions in the administration of sedative drugs.

Material and method

AWARE is a randomized, controlled, open, multicentre trial performed in parallel groups. Patients will be included if over 18 years old and admitted to the ICU with the need for invasive mechanical ventilation for a previsible duration of >48 hours. Inclusion should be performed before the first 12 hours of intubation and ventilation. Patients will be randomly split into two groups of equal patients. The control group will receive the usual level of sedation in the department, while the treatment group will receive sedation according to the reduced sedation approach. The tested strategy relies the identification of different clinical situations of increasing severity (level 0 to 3), to which specific therapeutic responses will be assigned (type 0 to 3). The main objective is to reduce mortality at D90. In order to show a reduction in mortality at D90 of 22 to 17%, the number of patients to be included is 2,720 (1,360 per arm), with an alpha risk of 5% and a power of 90%. The number of centres will be about 140 to 150. The inclusion duration is for 24 months.