Frequency of screening and SBT Technique Trial—North American Weaning Collaboration (FAST-NAWC): an update to the protocol and statistical analysis plan
Karen E. A. Burns,
Myriam Lafrienier-Roula,
Nicholas S. Hill,
Deborah J. Cook,
Andrew J. E. Seely,
Bram Rochwerg,
Michael Mayette,
Frederick D’Aragon,
John W. Devlin,
Peter Dodek,
Maged Tanios,
Audrey Gouskos,
Alexis F. Turgeon,
Pierre Aslanian,
Ying Tung Sia,
Jeremy R. Beitler,
Robert Hyzy,
Gerard J. Criner,
Elias Baedorf Kassis,
Jennifer L. Y. Tsang,
Maureen O. Meade,
Janice M. Liebler,
Jessica T. Y. Wong,
Kevin E. Thorpe,
For the Canadian Critical Care Trials Group
Affiliations
Karen E. A. Burns
Interdepartmental Division of Critical Care, University of Toronto
Myriam Lafrienier-Roula
Applied Health Research Centre, St. Michael’s Hospital
Nicholas S. Hill
Division of Pulmonary, Critical Care and Sleep Medicine, Tufts Medical Center
Deborah J. Cook
Department of Health Research Methods, Evidence and Impact, McMaster University
Andrew J. E. Seely
Ottawa Hospital Research Institute, University of Ottawa
Bram Rochwerg
Department of Health Research Methods, Evidence and Impact, McMaster University
Michael Mayette
Centre Hospitalier Universitaire de Sherbrooke
Frederick D’Aragon
Centre Hospitalier Universitaire de Sherbrooke
John W. Devlin
Bouve College of Health Professions, Northeastern University
Peter Dodek
Centre for Health Evaluation and Outcome Sciences
Maged Tanios
Pulmonary and Critical Care Medicine, Memorial Care, Longbeach Medical Center
Audrey Gouskos
Patient and Family Advisory Committee and Steering Committee Representative, FAST-NAWC Trial
Alexis F. Turgeon
Departments of Anesthesia and Critical Care, Hôpital Enfant-Jésus du CHU de Québec-Université Laval
Pierre Aslanian
Service de Soins Intensifs, Département de Médecine, Centre Hospitalier de L’Universite de Montreal
Ying Tung Sia
Department of Critical Care Medicine, Centre Integre Universitaire de Sante et de Services Sociaux de la Mauricie-et-du-Centre-du-Quebec – Trois Rivieres
Jeremy R. Beitler
Center for Acute Respiratory Failure and Division of Pulmonary, Allergy, and Critical Care Medicine, Columbia University College of Physicians and Surgeons and New York-Presbyterian Hospital
Robert Hyzy
Division of Pulmonary and Critical Care, University of Michigan Health System
Gerard J. Criner
Division of Pulmonary and Critical Care Medicine, Temple University, Lewis Katz School of Medicine
Elias Baedorf Kassis
Departments of Medicine (Division of Critical Care) and Anesthesia, Beth Israel Deaconess Medical Center
Jennifer L. Y. Tsang
Department of Medicine, McMaster University
Maureen O. Meade
Department of Health Research Methods, Evidence and Impact, McMaster University
Janice M. Liebler
Divisions of Pulmonary, Critical Care, and Sleep Medicine, Keck School of Medicine, University of Southern California
Jessica T. Y. Wong
Faculty of Medicine and Dentistry, University of Toronto
Kevin E. Thorpe
Applied Health Research Centre, St. Michael’s Hospital
Abstract Background This update summarizes key changes made to the protocol for the Frequency of Screening and Spontaneous Breathing Trial (SBT) Technique Trial—North American Weaning Collaborative (FAST-NAWC) trial since the publication of the original protocol. This multicenter, factorial design randomized controlled trial with concealed allocation, will compare the effect of both screening frequency (once vs. at least twice daily) to identify candidates to undergo a SBT and SBT technique [pressure support + positive end-expiratory pressure vs. T-piece] on the time to successful extubation (primary outcome) in 760 critically ill adults who are invasively ventilated for at least 24 h in 20 North American intensive care units. Methods/design Protocols for the pilot, factorial design trial and the full trial were previously published in J Clin Trials ( https://doi.org/10.4172/2167-0870.1000284 ) and Trials (https://doi: 10.1186/s13063-019–3641-8). As planned, participants enrolled in the FAST pilot trial will be included in the report of the full FAST-NAWC trial. In response to the onset of the coronavirus disease of 2019 (COVID-19) pandemic when approximately two thirds of enrollment was complete, we revised the protocol and consent form to include critically ill invasively ventilated patients with COVID-19. We also refined the statistical analysis plan (SAP) to reflect inclusion and reporting of participants with and without COVID-19. This update summarizes the changes made and their rationale and provides a refined SAP for the FAST-NAWC trial. These changes have been finalized before completion of trial follow-up and the commencement of data analysis. Trial registration Clinical Trials.gov NCT02399267.
