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Procedure
Patients under mechanical ventilation for Artificial Respiration (SEVERE Trial)
N/A
Recruiting
Led By Laurent Brochard
Research Sponsored by Unity Health Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 minute
Awards & highlights
SEVERE Trial Summary
This trial aims to study a phenomenon called reverse triggering in critically ill patients on mechanical ventilation. Reverse triggering occurs when the ventilator triggers the patient's breathing instead of the other way around. The study will
Who is the study for?
This trial is for adult patients who are critically ill and require mechanical ventilation in a mode called assist-control. Participants must be sedated and able to undergo changes in ventilator settings without risk. Specific criteria about health status or other conditions aren't provided, but typically, patients with unstable conditions would be excluded.Check my eligibility
What is being tested?
The study is testing how different ventilator settings (respiratory rate and tidal volume) affect the occurrence of reverse triggering—a condition where the ventilator initiates breaths instead of the patient—and its impact on respiratory muscle activity.See study design
What are the potential side effects?
While not explicitly listed, potential side effects may include discomfort from the change in breathing patterns, possible lung injury from inappropriate ventilation settings, or fatigue of respiratory muscles due to altered support.
SEVERE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 minute
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 minute
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
The magnitude of the effort, measured by the drop in the esophageal pressure in cmH2O, associated with the reverse triggered breaths after each change in the ventilator respiratory rate and tidal volume
The rate of of reverse triggered breaths occurring after each change in the ventilator respiratory rate and tidal volume.
SEVERE Trial Design
1Treatment groups
Experimental Treatment
Group I: Patients under mechanical ventilationExperimental Treatment1 Intervention
Patients intubated for more than 12 hours, on assist-control ventilation, not triggering the ventilator with or without reverse triggering, exposed to sedation for at least 6 hours, with a sedation-agitation score ≤ 4.
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Who is running the clinical trial?
Unity Health TorontoLead Sponsor
540 Previous Clinical Trials
447,750 Total Patients Enrolled
Laurent BrochardPrincipal InvestigatorUnity Health Toronto - St. Michael's Hospital
1 Previous Clinical Trials
575 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the current number of individuals actively enrolled in this research study?
"Yes, data from clinicaltrials.gov indicates that this research study is actively seeking participants. The trial was first listed on March 1st, 2024 and last revised on February 27th, 2024. It aims to recruit a total of 30 patients from one specific site."
Answered by AI
Are there any ongoing efforts to enroll participants for this particular trial?
"According to the details provided on clinicaltrials.gov, this research investigation is currently in need of participants. The initial posting date for this study was 3/1/2024 with the most recent update made on 2/27/2024."
Answered by AI
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