. 2019 Oct 11;20(1):587.

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

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.

PMID: 31604480
PMCID: PMC6787986
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

K E A Burns et al. Trials. 2019.

. 2019 Oct 11;20(1):587.

doi: 10.1186/s13063-019-3641-8.

Authors

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.

PMID: 31604480
PMCID: PMC6787986
DOI: 10.1186/s13063-019-3641-8

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.

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Conflict of interest statement

The authors declare that they have no competing interests.

Figures

**Fig. 1**
Cumulative hazard and survival functions of patients infected by K. pneumoniae fitted to Lognormal distribution

See this image and copyright information in PMC

References

1. Esteban A, Alia I, Ibanez J, Benito S, Tobin MJ. Modes of mechanical ventilation and weaning. A national survey of Spanish hospitals. The Spanish Lung Failure Collaborative Group. Chest. 1994;106:1188–1193. doi: 10.1378/chest.106.4.1188. - DOI - PubMed
1. Esteban A, Anzueto A, Frutos F, et al. Characteristics and outcomes in adult patients receiving mechanical ventilation: a 28-day international study. JAMA. 2002;287(3):345–355. doi: 10.1001/jama.287.3.345. - DOI - PubMed
1. Pingleton SK. Complications of acute respiratory failure. Am Rev Respir Dis. 1988;137:1463–1493. doi: 10.1164/ajrccm/137.6.1463. - DOI - PubMed
1. Heyland DK, Cook DJ, Griffith L, Keenan SP, Brun-Buisson C. The attributable morbidity and mortality of ventilator associated pneumonia in the critically ill patient. The Canadian Critical Care Trials Group. Am J Respir Crit Care Med. 1999;159:1249–1256. doi: 10.1164/ajrccm.159.4.9807050. - DOI - PubMed
1. Thille AW, Harrois A, Schortgen F, Brun-Buisson C, Brochard L. Outcomes of extubation failure in medical intensive care unit patients. Crit Care Med. 2011;39:2612–2618. doi: 10.1097/CCM.0b013e3182282a5a. - DOI - PubMed

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

Affiliations

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

Authors

Affiliations

Abstract

Conflict of interest statement

Figures

References

Publication types

MeSH terms

Associated data

Grants and funding

LinkOut - more resources

Full Text Sources

Medical