Frequency of Screening and SBT Technique Trial

Status unconfirmed · Not applicable

Conditions studied: Critically Ill

In brief

The requirement for invasive mechanical ventilation is a defining feature of critical illness. Liberation or weaning is the process during which the work of breathing is transferred from the ventilator back to the patient. Approximately 40% of the time spent on mechanical ventilation is dedicated to weaning. Limiting the duration of invasive ventilation has been identified as a key research priority in critical care. Studies support the use of screening protocols (once daily vs. usual care) to identify weaning candidates and the conduct of tests of patient's ability to breathe spontaneously (SBTs). While once daily screening is the current standard of care in national intensive care units (ICUs), it is poorly aligned with the 24/7 ICU care environment wherein a critically ill patients' status can change from hour to hour. Only one large trial has compared alternative SBT techniques \[T-piece vs PS (Pressure Support)\]. No trial has compared a strategy of more frequent screening to once daily screening or alternative SBT techniques. The presence of respiratory therapists (RTs) 24/7 in North American ICUs presents a unique opportunity to screen more frequently, conduct more frequent SBTs, and determine the optimal strategy to liberate critically ill adults from invasive ventilation. The investigators propose to conduct a pilot randomized trial in 100 critically ill adults comparing 'once daily' screening to 'at least twice daily' screening and PS vs. T-piece SBTs in 12 Canadian ICUs. In the proposed trial, the investigators will (i) assess their ability to recruit critically ill adults who can breathe spontaneously or initiate breaths on one of several commonly used modes of ventilation into the trial, (ii) evaluate clinician's ability to implement the trial as designed, (iii) assess current practices in sedation, analgesia and delirium management and timing of patient mobilization prior to conducting screening assessments, (iv) identify barriers (clinician, institutional) to enrolling patients, (v) characterize trial participants based on weaning difficulty, and (vi) obtain preliminary estimates of the impact of the alternative screening and SBT strategies on clinically important outcomes.

Key facts

Study ID

NCT02399267

Run by

Unity Health Toronto

People needed

100

Starts

2016-07-01

Expected to finish

2021-12-01

Last updated by the study team

2019-04-04

Who can join

Age: 16 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• The investigators will include patients who are:
• receiving invasive mechanical ventilation for >= 24 hours.
• capable of initiating spontaneous breaths on Pressure Support (PS) or Proportional Assist Ventilation (PAV) or triggering breaths on volume or pressure Assist Control (AC), volume or pressure Synchronized Intermittent Mandatory Ventilation (SIMV) ± PS, Pressure Regulated Volume Control (PRVC) or (Airway Pressure Release Ventilation) APRV,
• with a fraction of inspired oxygen (FiO2) of =< 70% and
• with a positive end-expiratory pressure (PEEP) of =< 12 cm H2O.

You may not qualify if…

• The investigators will exclude patients who are
• admitted after cardiopulmonary arrest or with brain death or expected brain death,
• who have evidence of myocardial ischemia in the 24 hour period before enrollment,
• who have received continuous invasive mechanical ventilation for >= 2 weeks,
• who have a tracheostomy in situ at the time of screening,
• who are receiving sedative infusions for seizures or alcohol withdrawal,
• who require escalating doses of sedative agents,
• who are receiving neuromuscular blockers or who have known quadriplegia, paraplegia or 4 limb weakness or paralysis preventing active mobilization (e.g., active range of motion, exercises in bed, sitting at edge of bed, transferring from bed to chair, standing, marching in place, ambulating),
• who are moribund (e.g., at imminent risk for death) or who have limitations of treatment (e.g., withdrawal of support, do not reintubate order, however, do not resuscitate orders will be permitted),
• who have profound neurologic deficits (e.g. large intracranial stroke or bleed) or Glasgow Coma Scale (GCS) < 6,
• who are using modes that automate SBT conduct,
• who are current enrolled in a confounding study that includes a weaning protocol, or
• who were previously enrolled in this trial,
• patients who have already undergone an SBT or who are on settings compatible with an SBT (T-piece, CPAP without PS (any level), or PS (=< 8 cm H2O regardless of PEEP)
• patients who have already undergone extubation [planned, unplanned (e.g. self, accidental)] during the same ICU admission.

Where it is running

• Longbeach Memorial Hospital — Long Beach, California, United States
• Grady Memorial Hospital — Atlanta, Georgia, United States
• St Paul's Hospital — Vancouver, British Columbia, Canada
• Juravinski Hospital — Hamilton, Ontario, Canada
• St. Joseph's Hospital — Hamilton, Ontario, Canada
• Ottawa Civic Hospital — Ottawa, Ontario, Canada
• Ottawa General Hospital — Ottawa, Ontario, Canada
• St. Michael's Hospital — Toronto, Ontario, Canada
• St. Joseph's Hospital, Toronto — Toronto, Ontario, Canada
• Universite de Sherbrooke — Sherbrooke, Quebec, Canada

Full record on ClinicalTrials.gov

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