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

Adult Humans Ventilator Weaning / methods Critical Illness COVID-19 Time Factors North America Respiration, Artificial Randomized Controlled Trials as Topic Multicenter Studies as Topic
Randomized controlled trial Screening Spontaneous breathing trial Successful extubation Weaning

Journal

Trials
ISSN: 1745-6215
Titre abrégé: Trials
Pays: England
ID NLM: 101263253

Informations de publication

Date de publication:
02 Oct 2023
Historique:
received: 01 12 2022
accepted: 05 01 2023
medline: 4 10 2023
pubmed: 3 10 2023
entrez: 2 10 2023
Statut: epublish

Résumé

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. 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. Clinical Trials.gov NCT02399267.

Sections du résumé

BACKGROUND 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 METHODS
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 BACKGROUND
Clinical Trials.gov NCT02399267.

Identifiants

DOI: 10.1186/s13063-023-07079-5 PMID: 37784109 PMC: PMC10544476
pubmed: 37784109
doi: 10.1186/s13063-023-07079-5
pii: 10.1186/s13063-023-07079-5
pmc: PMC10544476
doi:

Banques de données

ClinicalTrials.gov
['NCT02399267']

Types de publication

Clinical Trial Protocol Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

626

Subventions

Organisme : Canadian Institute for Health Research
ID : RC2 392239

Informations de copyright

© 2023. BioMed Central Ltd., part of Springer Nature.

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Auteurs

Karen E A Burns (KEA)

Interdepartmental Division of Critical Care, University of Toronto, Toronto, Canada. karen.burns@unityhealth.to.
Division of Critical Care Medicine, St Michael's Hospital, Toronto, Canada. karen.burns@unityhealth.to.
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.
ORCID: 0000-0002-9967-5424

Myriam Lafrienier-Roula (M)

Applied Health Research Centre, St. Michael's Hospital, Toronto, Canada.

Nicholas S Hill (NS)

Division of Pulmonary, Critical Care and Sleep Medicine, Tufts Medical Center, Boston, USA.

Deborah J Cook (DJ)

Department of Health Research Methods, Evidence and Impact, McMaster University, Hamilton, Canada.

Andrew J E Seely (AJE)

Ottawa Hospital Research Institute, University of Ottawa, Ottawa, Canada.

Bram Rochwerg (B)

Department of Health Research Methods, Evidence and Impact, McMaster University, Hamilton, Canada.
Department of Medicine, McMaster University, Hamilton, Canada.

Michael Mayette (M)

Centre Hospitalier Universitaire de Sherbrooke, Sherbrooke, Canada.
Centre de Recherche du Centre Hospitalier, Universitaire de Sherbrooke, Sherbrooke, Canada.

Frederick D'Aragon (F)

Centre Hospitalier Universitaire de Sherbrooke, Sherbrooke, Canada.
Centre de Recherche du Centre Hospitalier, Universitaire de Sherbrooke, Sherbrooke, Canada.

John W Devlin (JW)

Bouve College of Health Professions, Northeastern University, Boston, USA.
Division of Pulmonary and Critical Care Medicine, Brigham and Women's Hospital, Boston, MA, USA.

Peter Dodek (P)

Centre for Health Evaluation and Outcome Sciences, Vancouver, Canada.
University of British Columbia, Vancouver, Canada.

Maged Tanios (M)

Pulmonary and Critical Care Medicine, Memorial Care, Longbeach Medical Center, Longbeach, CA, USA.

Audrey Gouskos (A)

Patient and Family Advisory Committee and Steering Committee Representative, FAST-NAWC Trial, Toronto, Canada.

Alexis F Turgeon (AF)

Departments of Anesthesia and Critical Care, Hôpital Enfant-Jésus du CHU de Québec-Université Laval, Quebec City, Canada.

Pierre Aslanian (P)

Service de Soins Intensifs, Département de Médecine, Centre Hospitalier de L'Universite de Montreal, Montreal, Canada.

Ying Tung Sia (YT)

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.

Jeremy R Beitler (JR)

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.

Robert Hyzy (R)

Division of Pulmonary and Critical Care, University of Michigan Health System, Ann Arbor, MI, USA.

Gerard J Criner (GJ)

Division of Pulmonary and Critical Care Medicine, Temple University, Lewis Katz School of Medicine, Philadelphia, USA.

Elias Baedorf Kassis (EB)

Departments of Medicine (Division of Critical Care) and Anesthesia, Beth Israel Deaconess Medical Center, Boston, USA.

Jennifer L Y Tsang (JLY)

Department of Medicine, McMaster University, Hamilton, Canada.
Department of Medicine, Division of Critical Care, Niagara Health System - St. Catherines, St. Catherines, Canada.

Maureen O Meade (MO)

Department of Health Research Methods, Evidence and Impact, McMaster University, Hamilton, Canada.
Department of Medicine, McMaster University, Hamilton, Canada.
Division of Critical Care, Hamilton Health Sciences Center, Hamilton, Canada.

Janice M Liebler (JM)

Divisions of Pulmonary, Critical Care, and Sleep Medicine, Keck School of Medicine, University of Southern California, Los Angeles, USA.

Jessica T Y Wong (JTY)

Faculty of Medicine and Dentistry, University of Toronto, Toronto, Canada.

Kevin E Thorpe (KE)

Applied Health Research Centre, St. Michael's Hospital, Toronto, Canada.
Institute for Health Policy, Management and Evaluation, University of Toronto, Toronto, Canada.

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Classifications MeSH

questionsmedicales.fr › Personnes › Tranches d'âge › Adulte › Frequency of screening and SBT Technique...
questionsmedicales.fr › Eucaryotes › Animaux › Chordés › Vertébrés › Mammifères › Eutheria › Primates › Haplorhini › Catarrhini › Hominidae › Humains › Frequency of screening and SBT Technique...
questionsmedicales.fr › Thérapeutique › Thérapie respiratoire › Ventilation artificielle › Sevrage de la ventilation mécanique › Frequency of screening and SBT Technique...
questionsmedicales.fr › États, signes et symptômes pathologiques › Processus pathologiques › Caractéristiques de la maladie › Maladie grave › Frequency of screening and SBT Technique...
questionsmedicales.fr › Maladies de l'appareil respiratoire › Infections de l'appareil respiratoire › Pneumopathie infectieuse › Pneumopathie virale › COVID-19 › Frequency of screening and SBT Technique...
questionsmedicales.fr › Phénomènes physiques › Temps › Facteurs temps › Frequency of screening and SBT Technique...
questionsmedicales.fr › Régions géographiques › Amériques › Amérique du Nord › Frequency of screening and SBT Technique...
questionsmedicales.fr › Thérapeutique › Thérapie respiratoire › Ventilation artificielle › Frequency of screening and SBT Technique...
questionsmedicales.fr › Environnement et santé publique › Santé publique › Méthodes épidémiologiques › Caractéristiques des études épidémiologiques › Études cliniques comme sujet › Essais cliniques comme sujet › Essais cliniques contrôlés comme sujet › Essais contrôlés randomisés comme sujet › Frequency of screening and SBT Technique...
questionsmedicales.fr › Environnement et santé publique › Santé publique › Méthodes épidémiologiques › Caractéristiques des études épidémiologiques › Études multicentriques comme sujet › Frequency of screening and SBT Technique...