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Parallel Pilot Trials of Screening Frequency for Liberation from Mechanical Ventilation the RELEASE Trial and SENIOR Trial Protocols

Karen EA Burns, Jessica TY Wong, Leena Rizvi, Lori Hand, Deborah J Cook, Peter Dodek, Sangeeta Mehta, Michelle E Kho PT, Francois Lamontagne, Jan O. Friedrich, Andrew J Seely, Laurent Brochard, Eddy Fan, Christine Leger, Fatma Rajwani, Julia Lee RRT, Kevin Thorpe and Maureen O Meade

Rationale: Reducing the duration of invasive ventilation is a priority in the intensive care unit (ICU). Once daily screening to identify candidates for spontaneous breathing trials (SBTs) is poorly aligned with the continuous care ICU environment. Objectives: The primary objective of the pilot randomized RELEASE and SENIOR trials is to assess our ability to recruit 50 non-elderly (<65 years) and 100 elderly (> 65 years) critically ill adults into parallel trials comparing once vs at least twice daily screening. Secondary objectives are to evaluate clinicians’ adherence to the screening protocols, assess current practices related to management of sedation, analgesia, delirium and patient mobilization before screening assessments, identify barriers to enrollment, characterize trial participants based on weaning difficulty, and obtain preliminary estimates of the alternative screening strategies on clinical outcomes. In the SENIOR trial, we will also compare recruitment metrics and intervention effect between elderly (65 to 80 years) and very elderly (>80 years) participants. Methods: In both trials, we will enroll critically ill adults receiving invasive ventilation for at least 24 hours who can initiate or trigger breaths. In both arms, Respiratory Therapists (RTs) will screen patients between 06:00 and 08:00 hours daily to identify SBT candidates. In the ‘at least twice daily screening’ arm, RTs will also screen patients between 13:00 and 15:00 hours with additional screening periods permitted at clinicians’ discretion. We will consider the studies feasible if we can recruit on average, 1 to 2 patients per month per ICU and attain at least 80% protocol adherence. Relevance: Screening patients more frequently and conducting more frequent SBTs has the potential to reduce the duration of time spent on invasive ventilation and in the ICU. Information garnered from these pilot randomized trials will inform the design of a large, future trial. Clinical trial study: The RELEASE Trial ClinicalTrials.gov Identifier: NCT02001220; The SENIOR Trial ClinicalTrials.gov Identifier: NCT02243449