CompletedNot Applicable

Screening Frequency Trial to Identify Weaning Candidates

Canada53 participantsStarted 2015-01

Plain-language summary

During weaning the work of breathing is transferred from the ventilator back to the patient. Approximately 40% of the time on ventilators is spent weaning. Studies support the use of screening protocols and tests of patient's ability to breathe spontaneously (SBTs) to identify weaning candidates. Once daily screening is the current standard of care. With respiratory therapists (RTs) in Canadian intensive care units (ICUs), a significant opportunity exists to screen patients more frequently, conduct more SBTs, and reduce the time spent on ventilators and in the ICU. The study is seeking to identify the optimal screening frequency to minimize patients' exposure to invasive ventilation. The RELEASE Trial will evaluate a simple a simple construct: more frequent screening will result In earlier identification of weaning candidates, more frequent SBT's, and less time spent on ventilators and in the ICU. More frequent screening is an appealing intervention because it is sensible, low risk, and represents a cost effective use of current resources. This simple intervention holds promise as a strategy that could change clinical practice, enhance the care delivered to critically ill adults, and improve clinically important outcomes.

Who can participate

Age range

16 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Receiving invasive mechanical ventilation for ≥ 24 hours. * Capable of initiating spontaneous breaths on PS or triggering breaths on volume or pressure AC, volume or pressure SIMV ± PS, PRVC, or APRV. * With an FiO2 ≤ 70%. * With a PEEP ≤ 12 cm H₂O. * \< 65 years of age Exclusion Criteria: * Patients admitted after cardiopulmonary arrest or with brain death or expected brain death. * Patients who have evidence of myocardial ischemia in the 24 hour period before enrollment. * Patients who have received continuous invasive mechanical ventilation for ≥ 2 weeks. * Patients who have a tracheostomy in situ at the time of screening. * Patients who are receiving sedative infusions for seizures or alcohol withdrawal. * Patients who require escalating doses of sedative agents. * Patients 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). * Patients 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). * Patients who have profound neurologic deficits (e.g., large intracranial stroke or bleed) or Glasgow Coma Scale (GCS) ≤ 6. * Patients who are using modes that automate SBT conduct.…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

To demonstrate our ability to recruit the desired population (1-2 patients, per centre per month, on average)

Timeframe: 2 years

Trial details

NCT IDNCT02001220

SponsorUnity Health Toronto

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2015-09

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