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

doi:10.1186/s13063-019-3641-8

Abstract

RationaleIn 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.ObjectivesTo identify the optimal screening frequency and SBT technique to wean critically ill adults in the ICU.MethodsWe 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.RelevanceThe 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 registrationClinical Trials.gov, NCT02399267. Registered on Nov 21, 2016 first registered.

Highlights

Weaning from invasive mechanical ventilation (MV) is the process during which the work of breathing is transferred from the ventilator back to the patient
Invasive MV is effective in managing respiratory failure, its use is associated with the development of numerous complications including ventilator-associated pneumonia (VAP) and respiratory muscle weakness [3]
In their efforts to minimize patient’s exposure to invasive MV, clinicians are challenged by a “tradeoff” between the complications associated with protracted ventilation and the risks associated with failed attempts at extubation [8]

Summary

Introduction

Weaning from invasive mechanical ventilation (MV) is the process during which the work of breathing is transferred from the ventilator back to the patient. The risk for VAP increases after the fifth day of invasive MV, is associated with substantial morbidity, and may increase mortality [4]. Premature or failed attempts at extubation necessitating reintubation are associated with greater risk of VAP [5], prolonged intensive care unit (ICU) stay, and increased mortality [6, 7]. In their efforts to minimize patient’s exposure to invasive MV, clinicians are challenged by a “tradeoff” between the complications associated with protracted ventilation and the risks associated with failed attempts at extubation [8]

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