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Published in: Trials 1/2019

Open Access 01-12-2019 | Study protocol

Frequency of Screening and SBT Technique Trial - North American Weaning Collaboration (FAST-NAWC): a protocol for a multicenter, factorial randomized trial

Authors: K. E. A. Burns, Leena Rizvi, Deborah J. Cook, Andrew J. E. Seely, Bram Rochwerg, Francois Lamontagne, John W. Devlin, Peter Dodek, Michael Mayette, Maged Tanios, Audrey Gouskos, Phyllis Kay, Susan Mitchell, Kenneth C. Kiedrowski, Nicholas S. Hill, For the Canadian Critical Care Trials Group

Published in: Trials | Issue 1/2019

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Abstract

Rationale

In critically ill patients receiving invasive mechanical ventilation (MV), research supports the use of daily screening to identify patients who are ready to undergo a spontaneous breathing trial (SBT) followed by conduct of an SBT. However, once daily (OD) screening is poorly aligned with the continuous care provided in most intensive care units (ICUs) and the best SBT technique for clinicians to use remains controversial.

Objectives

To identify the optimal screening frequency and SBT technique to wean critically ill adults in the ICU.

Methods

We aim to conduct a multicenter, factorial design randomized controlled trial with concealed allocation, comparing the effect of both screening frequency (once versus at least twice daily [ALTD]) and SBT technique (Pressure Support [PS] + Positive End-Expiratory Pressure [PEEP] 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 ICUs. In the OD arm, respiratory therapists (RTs) will screen study patients between 06:00 and 08:00 h. In the ALTD arm, patients will be screened at least twice daily between 06:00 and 08:00 h and between 13:00 and 15:00 h with additional screens permitted at the clinician’s discretion. When the SBT screen is passed, an SBT will be conducted using the assigned technique (PS + PEEP or T-piece). We will follow patients until successful extubation, death, ICU discharge, or until day 60 after randomization. We will contact patients or their surrogates six months after randomization to assess health-related quality of life and functional status.

Relevance

The around-the-clock availability of RTs in North American ICUs presents an important opportunity to identify the optimal SBT screening frequency and SBT technique to minimize patients’ exposure to invasive ventilation and ventilator-related complications.

Trial registration

Clinical Trials.gov, NCT02399267. Registered on Nov 21, 2016 first registered.
Appendix
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Metadata
Title
Frequency of Screening and SBT Technique Trial - North American Weaning Collaboration (FAST-NAWC): a protocol for a multicenter, factorial randomized trial
Authors
K. E. A. Burns
Leena Rizvi
Deborah J. Cook
Andrew J. E. Seely
Bram Rochwerg
Francois Lamontagne
John W. Devlin
Peter Dodek
Michael Mayette
Maged Tanios
Audrey Gouskos
Phyllis Kay
Susan Mitchell
Kenneth C. Kiedrowski
Nicholas S. Hill
For the Canadian Critical Care Trials Group
Publication date
01-12-2019
Publisher
BioMed Central
Published in
Trials / Issue 1/2019
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-019-3641-8

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