Karen E A Burns1,2,3, Jessica T Y Wong2, Peter Dodek4, Deborah J Cook5,6, Francois Lamontagne7, Ashley Cohen3,8, Sangeeta Mehta1,9, Michelle E Kho5,10, Paul C Hebert11, Pierre Aslanian11, Jan O Friedrich1,2,3, Laurent Brochard1,2,3, Leena Rizvi2, Lori Hand6, Maureen O Meade6, Andre C Amaral1,12, Andrew J Seely13. 1. Interdepartmental Division of Critical Care, University of Toronto, Toronto, ON, Canada. 2. Division of Critical Care Medicine, Department of Medicine, St Michael's Hospital, Toronto, ON, Canada. 3. Li Ka Shing Knowledge Institute, St. Michael's Hospital, Toronto, ON, Canada. 4. Centre for Health Evaluation and Outcome Sciences and Division of Critical Care Medicine, St Paul's Hospital and University of British Columbia, Vancouver, BC, Canada. 5. Division of Critical Care, St Joseph's Hospital, Hamilton, ON, Canada. 6. Departments of Medicine and Health Research Methods, Evidence and Impact, McMaster University, Hamilton, ON, Canada. 7. Division of Critical Care, Centre de Recherche du Centre Hospitalier Universitaire de Sherbrooke, Sherbrooke, QC, Canada. 8. Applied Health Research Centre, St. Michael's Hospital, Toronto, ON, Canada. 9. Division of Critical Care, Sinai Health System, Toronto, ON, Canada. 10. School of Rehabilitation Science, McMaster University, Hamilton, ON, Canada. 11. Division of Critical Care, Centre de recherche du Centre Hospitalier de l'Université de Montreal, Montreal, QC, Canada. 12. Department of Critical Care, Sunnybrook Health Sciences Centre, Toronto, ON, Canada. 13. Division of Critical Care, Ottawa Hospital Research Institute, University of Ottawa, Ottawa, ON, Canada.
Abstract
OBJECTIVES: It is unknown whether more frequent screening of invasively ventilated patients, identifies patients earlier for a spontaneous breathing trial, and shortens the duration of ventilation. We assessed the feasibility of conducting a large trial to evaluate screening frequency in critically ill adults in the North American context. DESIGN: We conducted two contemporaneous, multicenter, pilot, randomized controlled trials (the LibeRation from MEchanicaL VEntilAtion and ScrEening Frequency [RELEASE] and Screening Elderly PatieNts For InclusiOn in a Weaning [SENIOR] trials) to address concerns regarding the potential for higher enrollment, fewer adverse events, and better outcomes in younger patients. SETTING: Ten and 11 ICUs in Canada, respectively. PATIENTS: Parallel trials of younger (RELEASE < 65 yr) and older (SENIOR ≥ 65 yr) critically ill adults invasively ventilated for at least 24 hours. INTERVENTIONS: Each trial compared once daily screening to "at least twice daily" screening led by respiratory therapists. MEASUREMENTS AND MAIN RESULTS: In both trials, we evaluated recruitment (aim: 1-2 patients/month/ICU) and consent rates, reasons for trial exclusion, protocol adherence (target: ≥ 80%), crossovers (aim: ≤ 10%), and the effect of the alternative screening frequencies on adverse events and clinical outcomes. We included 155 patients (53 patients [23 once daily, 30 at least twice daily] in RELEASE and 102 patients [54 once daily, 48 at least twice daily] in SENIOR). Between trials, we found similar recruitment rates (1.32 and 1.26 patients/month/ICU) and reasons for trial exclusion, high consent and protocol adherence rates (> 92%), infrequent crossovers, and few adverse events. Although underpowered, at least twice daily screening was associated with a nonsignificantly faster time to successful extubation and more successful extubations but significantly increased use of noninvasive ventilation in both trials combined. CONCLUSIONS: Similar recruitment and consent rates, few adverse events, and comparable outcomes in younger and older patients support conduct of a single large trial in North American ICUs assessing the net clinical benefits associated with more frequent screening.
RCT Entities:
OBJECTIVES: It is unknown whether more frequent screening of invasively ventilated patients, identifies patients earlier for a spontaneous breathing trial, and shortens the duration of ventilation. We assessed the feasibility of conducting a large trial to evaluate screening frequency in critically ill adults in the North American context. DESIGN: We conducted two contemporaneous, multicenter, pilot, randomized controlled trials (the LibeRation from MEchanicaL VEntilAtion and ScrEening Frequency [RELEASE] and Screening Elderly PatieNts For InclusiOn in a Weaning [SENIOR] trials) to address concerns regarding the potential for higher enrollment, fewer adverse events, and better outcomes in younger patients. SETTING: Ten and 11 ICUs in Canada, respectively. PATIENTS: Parallel trials of younger (RELEASE < 65 yr) and older (SENIOR ≥ 65 yr) critically ill adults invasively ventilated for at least 24 hours. INTERVENTIONS: Each trial compared once daily screening to "at least twice daily" screening led by respiratory therapists. MEASUREMENTS AND MAIN RESULTS: In both trials, we evaluated recruitment (aim: 1-2 patients/month/ICU) and consent rates, reasons for trial exclusion, protocol adherence (target: ≥ 80%), crossovers (aim: ≤ 10%), and the effect of the alternative screening frequencies on adverse events and clinical outcomes. We included 155 patients (53 patients [23 once daily, 30 at least twice daily] in RELEASE and 102 patients [54 once daily, 48 at least twice daily] in SENIOR). Between trials, we found similar recruitment rates (1.32 and 1.26 patients/month/ICU) and reasons for trial exclusion, high consent and protocol adherence rates (> 92%), infrequent crossovers, and few adverse events. Although underpowered, at least twice daily screening was associated with a nonsignificantly faster time to successful extubation and more successful extubations but significantly increased use of noninvasive ventilation in both trials combined. CONCLUSIONS: Similar recruitment and consent rates, few adverse events, and comparable outcomes in younger and older patients support conduct of a single large trial in North American ICUs assessing the net clinical benefits associated with more frequent screening.
Authors: Katie O'Hearn; Jess Gibson; Karla Krewulak; Rebecca Porteous; Victoria Saigle; Margaret Sampson; Anne Tsampalieros; Nick Barrowman; Saoirse Cameron Journal: Can J Anaesth Date: 2021-12-14 Impact factor: 6.713
Authors: Zhong-Hua Shi; Annemijn H Jonkman; Pieter Roel Tuinman; Guang-Qiang Chen; Ming Xu; Yan-Lin Yang; Leo M A Heunks; Jian-Xin Zhou Journal: Ann Transl Med Date: 2021-04
Authors: K E A Burns; Leena Rizvi; Deborah J Cook; Andrew J E Seely; Bram Rochwerg; Francois Lamontagne; John W Devlin; Peter Dodek; Michael Mayette; Maged Tanios; Audrey Gouskos; Phyllis Kay; Susan Mitchell; Kenneth C Kiedrowski; Nicholas S Hill Journal: Trials Date: 2019-10-11 Impact factor: 2.279