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.

Details

Title
Frequency of Screening and SBT Technique Trial - North American Weaning Collaboration (FAST-NAWC): a protocol for a multicenter, factorial randomized trial
Author
Burns, K. E. A. 1   VIAFID ORCID Logo  ; Rizvi, Leena 2 ; Cook, Deborah J. 3 ; Seely, Andrew J. E. 4 ; Rochwerg, Bram 5 ; Lamontagne, Francois 6 ; Devlin, John W. 7 ; Dodek, Peter 8 ; Mayette, Michael 6 ; Tanios, Maged 9 ; Gouskos, Audrey 10 ; Kay, Phyllis 10 ; Mitchell, Susan 10 ; Kiedrowski, Kenneth C. 10 ; Hill, Nicholas S. 11 

1  University of Toronto, Interdepartmental Division of Critical Care, Toronto, Canada (GRID:grid.17063.33) (ISNI:0000 0001 2157 2938); St Michael’s Hospital, Department of Medicine, Division of Critical Care Medicine, Toronto, Canada (GRID:grid.415502.7); St. Michael’s Hospital, Li Ka Shing Knowledge Institute, Toronto, Canada (GRID:grid.415502.7) 
2  St Michael’s Hospital, Department of Medicine, Division of Critical Care Medicine, Toronto, Canada (GRID:grid.415502.7) 
3  McMaster University, Department of Health Research Methods, Evidence and Impact, Hamilton, Canada (GRID:grid.25073.33) (ISNI:0000 0004 1936 8227) 
4  University of Ottawa, Ottawa Hospital Research Institute, Ottawa, Canada (GRID:grid.28046.38) (ISNI:0000 0001 2182 2255) 
5  McMaster University, Department of Health Research Methods, Evidence and Impact, Hamilton, Canada (GRID:grid.25073.33) (ISNI:0000 0004 1936 8227); McMaster University, Department of Medicine, Hamilton, Canada (GRID:grid.25073.33) (ISNI:0000 0004 1936 8227) 
6  Centre de Recherche du Centre Hospitalier Universitaire de Sherbrooke, Sherbrooke, Canada (GRID:grid.411172.0) (ISNI:0000 0001 0081 2808) 
7  Northeastern University, School of Pharmacy, Boston, USA (GRID:grid.261112.7) (ISNI:0000 0001 2173 3359); Tufts Medical Center, Division of Pulmonary, Critical Care and Sleep Medicine, Boston, USA (GRID:grid.67033.31) (ISNI:0000 0000 8934 4045) 
8  Centre for Health Evaluation and Outcome Sciences, Vancouver, Canada (GRID:grid.498725.5); University of British Columbia, Vancouver, Canada (GRID:grid.17091.3e) (ISNI:0000 0001 2288 9830) 
9  Longbeach Memorial, Critical Care Medicine, Longbeach, USA (GRID:grid.411172.0) 
10  FAST – NAWC Trial, Patient and Family Advisory Committee Member, Toronto, Canada (GRID:grid.411172.0) 
11  Tufts Medical Center, Division of Pulmonary, Critical Care and Sleep Medicine, Boston, USA (GRID:grid.67033.31) (ISNI:0000 0000 8934 4045) 
Pages
587
Publication year
2019
Publication date
Dec 2019
Publisher
Springer Nature B.V.
e-ISSN
17456215
Source type
Scholarly Journal
Language of publication
English
DOI
https://doi.org/10.1186/s13063-019-3641-8
ProQuest document ID
2795368542
Copyright
© The Author(s). 2019. This work is published under http://creativecommons.org/licenses/by/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.