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Parallel Pilot Trials of Screening Frequency for Liberation from Mechanical Ventilation the RELEASE Trial and SENIOR Trial Protocols | OMICS International | Abstract
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Journal of Clinical Trials
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Parallel Pilot Trials of Screening Frequency for Liberation from Mechanical Ventilation the RELEASE Trial and SENIOR Trial Protocols

Karen EA Burns123*, Jessica TY Wong2, Leena Rizvi 2, Lori Hand4, Deborah J Cook4,5, Peter Dodek6,7, Sangeeta Mehta2,3,8, Michelle E Kho PT9, Francois Lamontagne10, Jan O. Friedrich1,2,3, Andrew J Seely11, Laurent Brochard1,2,3, Eddy Fan1,12, Christine Leger2, Fatma Rajwani2, Julia Lee RRT2, Kevin Thorpe3,13 and Maureen O Meade4
1Interdepartmental Division of Critical Care, University of Toronto, Toronto, Canada
2Division of Critical Care Medicine, St Michael’s Hospital, Toronto, Canada
3Li Ka Shing Knowledge Institute, St. Michael’s Hospital, Toronto, Canada
4CLARITY, McMaster University, Hamilton, Canada
5St Joseph’s Hospital, Hamilton, Canada
6Centre for Health Evaluation and Outcome Sciences and Division of Critical Care Medicine, St Paul’s Hospital
7University of British Columbia, Vancouver, Canada
8Mount Sinai Hospital, Toronto, Canada
9School of Rehab Science, McMaster University, Hamilton, Canada
10Centre de Recherche du Centre Hospitalier Universitaire de Sherbrooke, Sherbrooke, Canada
11Ottawa Hospital Research Institute, University of Ottawa, Ottawa, Canada
12University Health Network, Toronto, Canada
13 Dalla Lana School of Public Health, Institute of Health Policy Management and Evaluation, Toronto, Canada
Corresponding Author : Karen E A Burns
Clinician Scientist, Department of Medicine
Division of Critical Care, St. Michael’s Hospital
and the Li Ka Shing Knowledge Institute,30 Bond Street
Office 4-045 Donnelly Wing Toronto, ONT, Canada
Tel: 416-864-6060 X3567
E-mail: [email protected]
Received: May 25, 2015 Accepted: July 22, 2015 Published: July 25, 2015
Citation: Burns KEA, Wong J, Rizvi L, Hand L, Cook DJ, et al. (2015) Parallel Pilot Trials of Screening Frequency for Liberation from Mechanical Ventilation the RELEASE Trial and SENIOR Trial Protocols. J Clin Trials 5:236. doi:10.4172/2167- 0870.1000236
Copyright: © 2015 Burns KEA, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
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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 Identifier: NCT02001220; The SENIOR Trial Identifier: NCT02243449


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