Evidence map›Paper›PMID 37784109›Full record

ArticleTrials2023

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 and 15 more

Registry-linked trialAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02399267 (The Frequency of Screening and SBT Technique Trial), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02399267 naunknown statusnot on this map

The Frequency of Screening and SBT Technique Trial

TypeinterventionalSponsorUnity Health TorontoRan2016 to 2021Enrolled100ConditionsCritically IllArmsOnce daily screening, Twice daily screening, PS SBTs, T-piece SBTs
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

25 authors.

Karen E A BurnsInterdepartmental Division of Critical Care, University of Toronto, Toronto, Canada. karen.burns@unityhealth.to.ORCID http://orcid.org/0000-0002-9967-5424
Myriam Lafrienier-RoulaApplied Health Research Centre, St. Michael's Hospital, Toronto, Canada.
Nicholas S HillDivision of Pulmonary, Critical Care and Sleep Medicine, Tufts Medical Center, Boston, USA.
Deborah J CookDepartment of Health Research Methods, Evidence and Impact, McMaster University, Hamilton, Canada.
Andrew J E SeelyOttawa Hospital Research Institute, University of Ottawa, Ottawa, Canada.
Bram RochwergDepartment of Health Research Methods, Evidence and Impact, McMaster University, Hamilton, Canada.
Michael MayetteCentre Hospitalier Universitaire de Sherbrooke, Sherbrooke, Canada.
Frederick D'AragonCentre Hospitalier Universitaire de Sherbrooke, Sherbrooke, Canada.
John W DevlinBouve College of Health Professions, Northeastern University, Boston, USA.
Peter DodekCentre for Health Evaluation and Outcome Sciences, Vancouver, Canada.
Maged TaniosPulmonary and Critical Care Medicine, Memorial Care, Longbeach Medical Center, Longbeach, CA, USA.
Audrey GouskosPatient and Family Advisory Committee and Steering Committee Representative, FAST-NAWC Trial, Toronto, Canada.
Alexis F TurgeonDepartments of Anesthesia and Critical Care, Hôpital Enfant-Jésus du CHU de Québec-Université Laval, Quebec City, Canada.
Pierre AslanianService de Soins Intensifs, Département de Médecine, Centre Hospitalier de L'Universite de Montreal, Montreal, Canada.
Ying Tung SiaDepartment 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 BeitlerCenter 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 HyzyDivision of Pulmonary and Critical Care, University of Michigan Health System, Ann Arbor, MI, USA.
Gerard J CrinerDivision of Pulmonary and Critical Care Medicine, Temple University, Lewis Katz School of Medicine, Philadelphia, USA.
Elias Baedorf KassisDepartments of Medicine (Division of Critical Care) and Anesthesia, Beth Israel Deaconess Medical Center, Boston, USA.
Jennifer L Y TsangDepartment of Medicine, McMaster University, Hamilton, Canada.
Maureen O MeadeDepartment of Health Research Methods, Evidence and Impact, McMaster University, Hamilton, Canada.
Janice M LieblerDivisions of Pulmonary, Critical Care, and Sleep Medicine, Keck School of Medicine, University of Southern California, Los Angeles, USA.
Jessica T Y WongFaculty of Medicine and Dentistry, University of Toronto, Toronto, Canada.
Kevin E ThorpeApplied Health Research Centre, St. Michael's Hospital, Toronto, Canada.
Canadian Critical Care Trials Group

Funding

Respiratory Drive in Acute Respiratory FailureR01HL168102 · NHLBI · NEW YORK UNIVERSITY SCHOOL OF MEDICINE · PI Jeremy R. Beitler · 2023 to 2026
$3.2M
Canadian Institute for Health Research RC2 392239NHLBI NIH HHS R01 HL168102
6 · The paper itself

Abstract

backgroundThis 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/

designProtocols 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 registrationClinical Trials.gov NCT02399267.

Indexed as

COVID-19Ventilator WeaningAdultCritical IllnessHumansMulticenter Studies as TopicNorth AmericaRandomized Controlled Trials as TopicRespiration, ArtificialTime FactorsRandomized controlled trialScreeningSpontaneous breathing trialSuccessful extubationWeaning

Identifiers

PMID37784109
PMCPMC10544476

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.