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

被引：1

作者：

Burns, Karen E. A. ^{[1
,2
,3
]}

Lafrienier-Roula, Myriam ^{[4
]}

Hill, Nicholas S. ^{[5
]}

Cook, Deborah J. ^{[6
]}

Seely, Andrew J. E. ^{[7
]}

Rochwerg, Bram ^{[6
,8
]}

Mayette, Michael ^{[9
,10
]}

D'Aragon, Frederick ^{[9
,10
]}

Devlin, John W. ^{[11
,12
]}

Dodek, Peter ^{[13
,14
]}

Tanios, Maged ^{[15
]}

Gouskos, Audrey ^{[16
]}

Turgeon, Alexis F. ^{[17
,18
]}

Aslanian, Pierre ^{[19
]}

Sia, Ying Tung ^{[20
]}

Beitler, Jeremy R. ^{[21
,22
,23
]}

Hyzy, Robert ^{[24
]}

Criner, Gerard J. ^{[25
]}

Kassis, Elias Baedorf ^{[26
]}

Tsang, Jennifer L. Y. ^{[8
,27
]}

Meade, Maureen O. ^{[6
,8
,28
]}

Liebler, Janice M. ^{[29
]}

Wong, Jessica T. Y. ^{[30
]}

Thorpe, Kevin E. ^{[4
,31
]}

机构：

[1] Univ Toronto, Interdept Div Crit Care, Toronto, ON, Canada

[2] St Michaels Hosp, Div Crit Care Med, Toronto, ON, Canada

[3] St Michaels Hosp, Li Ka Shing Knowledge Inst, 30 Bond St,Off 4-045 Donnelly Wing, Toronto, ON M5B 1W8, Canada

[4] St Michaels Hosp, Appl Hlth Res Ctr, Toronto, ON, Canada

[5] Tufts Med Ctr, Div Pulm Crit Care & Sleep Med, Boston, MA USA

[6] McMaster Univ, Dept Hlth Res Methods Evidence & Impact, Hamilton, ON, Canada

[7] Univ Ottawa, Ottawa Hosp Res Inst, Ottawa, ON, Canada

[8] McMaster Univ, Dept Med, Hamilton, ON, Canada

[9] Ctr Hosp Univ Sherbrooke, Sherbrooke, PQ, Canada

[10] Ctr Hosp Univ Sherbrooke, Ctr Rech, Sherbrooke, PQ, Canada

[11] Northeastern Univ, Bouve Coll Hlth Profess, Boston, MA USA

[12] Brigham & Womens Hosp, Div Pulm & Crit Care Med, Boston, MA USA

[13] Ctr Hlth Evaluat & Outcome Sci, Vancouver, BC, Canada

[14] Univ British Columbia, Vancouver, BC, Canada

[15] Longbeach Med Ctr, Pulm & Crit Care Med, Mem Care, Long Beach, CA USA

[16] FAST NAWC Trial, Patient & Family Advisory Comm & Steering Comm Rep, Toronto, ON, Canada

[17] Univ Laval, Hop Enfant Jesus, CHU Quebec, Dept Anesthesiol, Quebec City, PQ, Canada

[18] Univ Laval, Hop Enfant Jesus, CHU Quebec, Dept Crit Care, Quebec City, PQ, Canada

[19] Ctr Hosp Univ Montreal, Dept Med, Serv Soins Intens, Montreal, PQ, Canada

[20] Mauricie & du Ctr du Quebec Trois Rivieres, Dept Crit Care Med, Ctr Integre Univ Sante & Serv Sociaux, Montreal, PQ, Canada

[21] Columbia Univ Coll Phys & Surg, Ctr Acute Resp Failure, New York, NY USA

[22] Columbia Univ Coll Phys & Surg, Div Pulm Allergy & Crit Care Med, New York, NY USA

[23] New York Presbyterian Hosp, New York, NY USA

[24] Univ Michigan Hlth Syst, Div Pulm & Crit Care Med, Ann Arbor, MI USA

[25] Temple Univ, Lewis Katz Sch Med, Div Pulm & Crit Care Med, Philadelphia, PA USA

[26] Beth Israel Deaconess Med Ctr, Dept Med, Div Crit Care & Anesthesia, Boston, MA USA

[27] Niagara Hlth Syst St Catherines, Dept Med, Div Crit Care, St Catharines, ON, Canada

[28] Hamilton Hlth Sci Ctr, Div Crit Care, Hamilton, ON, Canada

[29] Univ Southern Calif, Keck Sch Med, Div Pulm Crit Care & Sleep Med, Los Angeles, CA USA

[30] Univ Toronto, Fac Med & Dent, Toronto, ON, Canada

[31] Univ Toronto, Inst Hlth Policy Management & Evaluat, Toronto, ON, Canada

来源：

TRIALS | 2023年 / 24卷 / 01期

基金：

加拿大健康研究院;

关键词：

Weaning; Spontaneous breathing trial; Screening; Randomized controlled trial; Successful extubation; INTENSIVE-CARE; MECHANICAL VENTILATION; SCALE; RISK;

D O I：

10.1186/s13063-023-07079-5

中图分类号：

R-3 [医学研究方法]; R3 [基础医学];

学科分类号：

1001 ;

摘要：

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.

引用

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