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^{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.

PMID: 37784109
PMCID: PMC10544476
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

Karen E A Burns et al. Trials. 2023.

. 2023 Oct 2;24(1):626.

doi: 10.1186/s13063-023-07079-5.

Authors

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.

PMID: 37784109
PMCID: PMC10544476
DOI: 10.1186/s13063-023-07079-5

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.

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Conflict of interest statement

The authors declare that they have no competing interests.

References

1. Burns KEA, Rizvi L, Cook DJ, Seely A, Rochwerg B, Lamontagne F, Devlin J, Dodek P, Mayette M, Tanios M, Gouskos A, Kay P, Mitchell S, Kiedrowski K, Hill N. Frequency of Screening and SBT Technique Trial – North American Weaning Collaborative: a protocol for a multicente, factorial randomized trial. Trials. 2019;20(1):587. doi: 10.1186/s13063-019-3641-8. - DOI - PMC - PubMed
1. Burns KEA, Rizvi L, Dodek P, Lamontagne F, Seely AJE, Rochwerg B, Tanios M, Piraino T, Honig E, Cirone R, Cook DJ. Frequency of screening and ‘Spontaneous Breathing Trial’ Technique Study (The FAST Trial): design of a multicentre, pilot, factorial randomized controlled trial. Clin Trials. 2016;6:284.
1. Burns KE, Jacob SK, Aguirre V, Gomes J, Mehta S, Rizvi L. Stakeholder engagement in trial design: survey of visitors to critically ill patients regarding preferences for outcomes and treatment options during weaning from mechanical ventilation. Ann Am Thorac Soc. 2016;13(11):1962–1968. doi: 10.1513/AnnalsATS.201606-445OC. - DOI - PubMed
1. Peigne V, Chaize M, Falissard B, et al. Important questions asked by family members of ICU patients. Crit Care Med. 2011;39:1365–1371. doi: 10.1097/CCM.0b013e3182120b68. - DOI - PubMed
1. Burns KE, Devlin J, Hill N. Patient and family engagement in designing and implementing a weaning trial: a novel research paradigm in critical care. Chest. 2017 Jul 4. pii: S0012–3692(17)31204–7. Chest. 2017 Oct;152(4):707–711. doi: 10.1177/0885066617729127. - PubMed

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

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

Authors

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Abstract

Conflict of interest statement

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