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

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; Canadian Critical Care Trials Group

doi:10.1186/s13063-019-3641-8

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

Trials. 2019 Oct 11;20(1):587. doi: 10.1186/s13063-019-3641-8.

Authors

K E A Burns^{1

2

3}, Leena Rizvi⁴, Deborah J Cook⁵, Andrew J E Seely⁶, Bram Rochwerg^{5

7}, Francois Lamontagne⁸, John W Devlin^{9

10}, Peter Dodek^{11

12}, Michael Mayette⁸, Maged Tanios¹³, Audrey Gouskos¹⁴, Phyllis Kay¹⁴, Susan Mitchell¹⁴, Kenneth C Kiedrowski¹⁴, Nicholas S Hill¹⁰; Canadian Critical Care Trials Group

Affiliations

¹ Interdepartmental Division of Critical Care, University of Toronto, Toronto, ON, Canada. burnsk@smh.ca.
² Department of Medicine, Division of Critical Care Medicine, St Michael's Hospital, 30 Bond Street, Office 4-045 Donnelly Wing, Toronto, ON, M5B 1W8, Canada. burnsk@smh.ca.
³ Li Ka Shing Knowledge Institute, St. Michael's Hospital, 30 Bond Street, Office 4-045 Donnelly Wing, Toronto, ON, M5B 1W8, Canada. burnsk@smh.ca.
⁴ Department of Medicine, Division of Critical Care Medicine, St Michael's Hospital, 30 Bond Street, Office 4-045 Donnelly Wing, Toronto, ON, M5B 1W8, Canada.
⁵ Department of Health Research Methods, Evidence and Impact, McMaster University, Hamilton, ON, Canada.
⁶ Ottawa Hospital Research Institute, University of Ottawa, Ottawa, ON, Canada.
⁷ Department of Medicine, McMaster University, Hamilton, ON, Canada.
⁸ Centre de Recherche du Centre Hospitalier Universitaire de Sherbrooke, Sherbrooke, QC, Canada.
⁹ School of Pharmacy, Northeastern University, Boston, MA, USA.
¹⁰ Division of Pulmonary, Critical Care and Sleep Medicine, Tufts Medical Center, Boston, MA, USA.
¹¹ Centre for Health Evaluation and Outcome Sciences, Vancouver, BC, Canada.
¹² University of British Columbia, Vancouver, BC, Canada.
¹³ Critical Care Medicine, Longbeach Memorial, Longbeach, CA, USA.
¹⁴ Patient and Family Advisory Committee Member, FAST - NAWC Trial, Toronto, Canada.

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.

Keywords: Randomized controlled trial; Screening; Spontaneous breathing trial; Successful extubation; Weaning.

Publication types

Clinical Trial Protocol

MeSH terms

Airway Extubation
Critical Illness / therapy*
Humans
Lung / physiopathology*
Multicenter Studies as Topic
North America
Predictive Value of Tests
Randomized Controlled Trials as Topic
Recovery of Function
Respiration*
Respiration, Artificial*
Respiratory Function Tests*
Time Factors
Treatment Outcome
Ventilator Weaning*

Associated data

ClinicalTrials.gov/NCT02399267

Grants and funding

NA/CAPMC/ CIHR/Canada