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; Canadian Critical Care Trials Group

doi:10.1186/s13063-023-07079-5

Frequency of screening and SBT Technique Trial-North American Weaning Collaboration (FAST-NAWC): an update to the protocol and statistical analysis plan

Trials. 2023 Oct 2;24(1):626. doi: 10.1186/s13063-023-07079-5.

Authors

Karen E A Burns^{1

2

3}, Myriam Lafrienier-Roula⁴, Nicholas S Hill⁵, Deborah J Cook⁶, Andrew J E Seely⁷, Bram Rochwerg^{6

8}, Michael Mayette^{9

10}, Frederick D'Aragon^{9

10}, John W Devlin^{11

12}, Peter Dodek^{13

14}, Maged Tanios¹⁵, Audrey Gouskos¹⁶, Alexis F Turgeon¹⁷, Pierre Aslanian¹⁸, Ying Tung Sia¹⁹, Jeremy R Beitler²⁰, Robert Hyzy²¹, Gerard J Criner²², Elias Baedorf Kassis²³, Jennifer L Y Tsang^{8

24}, Maureen O Meade^{6

8

25}, Janice M Liebler²⁶, Jessica T Y Wong²⁷, Kevin E Thorpe^{4

28}; Canadian Critical Care Trials Group

Affiliations

¹ Interdepartmental Division of Critical Care, University of Toronto, Toronto, Canada. karen.burns@unityhealth.to.
² Division of Critical Care Medicine, St Michael's Hospital, Toronto, Canada. karen.burns@unityhealth.to.
³ Li Ka Shing Knowledge Institute, St. Michael's Hospital, 30 Bond Street, Office 4-045 Donnelly Wing, Toronto, ON, M5B 1W8, Canada. karen.burns@unityhealth.to.
⁴ Applied Health Research Centre, St. Michael's Hospital, Toronto, Canada.
⁵ Division of Pulmonary, Critical Care and Sleep Medicine, Tufts Medical Center, Boston, USA.
⁶ Department of Health Research Methods, Evidence and Impact, McMaster University, Hamilton, Canada.
⁷ Ottawa Hospital Research Institute, University of Ottawa, Ottawa, Canada.
⁸ Department of Medicine, McMaster University, Hamilton, Canada.
⁹ Centre Hospitalier Universitaire de Sherbrooke, Sherbrooke, Canada.
¹⁰ Centre de Recherche du Centre Hospitalier, Universitaire de Sherbrooke, Sherbrooke, Canada.
¹¹ Bouve College of Health Professions, Northeastern University, Boston, USA.
¹² Division of Pulmonary and Critical Care Medicine, Brigham and Women's Hospital, Boston, MA, USA.
¹³ Centre for Health Evaluation and Outcome Sciences, Vancouver, Canada.
¹⁴ University of British Columbia, Vancouver, Canada.
¹⁵ Pulmonary and Critical Care Medicine, Memorial Care, Longbeach Medical Center, Longbeach, CA, USA.
¹⁶ Patient and Family Advisory Committee and Steering Committee Representative, FAST-NAWC Trial, Toronto, Canada.
¹⁷ Departments of Anesthesia and Critical Care, Hôpital Enfant-Jésus du CHU de Québec-Université Laval, Quebec City, Canada.
¹⁸ Service de Soins Intensifs, Département de Médecine, Centre Hospitalier de L'Universite de Montreal, Montreal, Canada.
¹⁹ Department of Critical Care Medicine, Centre Integre Universitaire de Sante et de Services Sociaux de la Mauricie-et-du-Centre-du-Quebec - Trois Rivieres, Montreal, Canada.
²⁰ 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, New York, NY, USA.
²¹ Division of Pulmonary and Critical Care, University of Michigan Health System, Ann Arbor, MI, USA.
²² Division of Pulmonary and Critical Care Medicine, Temple University, Lewis Katz School of Medicine, Philadelphia, USA.
²³ Departments of Medicine (Division of Critical Care) and Anesthesia, Beth Israel Deaconess Medical Center, Boston, USA.
²⁴ Department of Medicine, Division of Critical Care, Niagara Health System - St. Catherines, St. Catherines, Canada.
²⁵ Division of Critical Care, Hamilton Health Sciences Center, Hamilton, Canada.
²⁶ Divisions of Pulmonary, Critical Care, and Sleep Medicine, Keck School of Medicine, University of Southern California, Los Angeles, USA.
²⁷ Faculty of Medicine and Dentistry, University of Toronto, Toronto, Canada.
²⁸ Institute for Health Policy, Management and Evaluation, University of Toronto, Toronto, Canada.

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.

Keywords: Randomized controlled trial; Screening; Spontaneous breathing trial; Successful extubation; Weaning.

Publication types

Clinical Trial Protocol

MeSH terms

Adult
COVID-19*
Critical Illness
Humans
Multicenter Studies as Topic
North America
Randomized Controlled Trials as Topic
Respiration, Artificial
Time Factors
Ventilator Weaning* / methods

Associated data

ClinicalTrials.gov/NCT02399267

Grants and funding

RC2 392239/Canadian Institute for Health Research