Investigating how ventilator settings affect reverse triggering in sedated patients
Susceptibility for Entrainment: Role of Ventilator Settings on the Occurrence of Reverse Triggering and Its Physiological Consequences - the SEVeRe Study
This study tests how changing ventilator settings affects reverse triggering in sedated patients on mechanical ventilation to see if it makes a difference in their care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Unity Health Toronto Academic / other |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT06293976 on ClinicalTrials.gov |
What this trial studies
This study examines the phenomenon of reverse triggering in critically ill patients on mechanical ventilation. It aims to understand how different ventilator settings, specifically respiratory rate and tidal volume, influence the occurrence of reverse triggering and its physiological consequences. The study will involve 30 participants who are intubated and sedated, with equal representation of men and women. Participants will be assessed based on their ventilator waveforms to determine the presence or absence of reverse triggering, and interventions will include adjustments to ventilator settings to evaluate their effects.
Who should consider this trial
Good fit: Ideal candidates are critically ill patients aged 18 years or older who are intubated for more than 12 hours and have been sedated for at least 6 hours.
Not a fit: Patients with primary severe neurological disorders, previous lung transplants, or those currently using neuromuscular blocking agents may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved ventilator management strategies that enhance patient outcomes in critically ill patients.
How similar studies have performed: While reverse triggering is a recognized phenomenon, this specific investigation into the effects of ventilator settings on its occurrence is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria: * Patients intubated for more than 12 hours * On assist-control ventilation, not triggering the ventilator * Exposed to sedation for at least 6 hours * With a sedation-agitation score ≤ 4. Exclusion Criteria: * primary severe neurological disorders * previous lung transplant * contraindications for esophageal catheter insertion * current use of continuous neuromuscular blocking agents at the time of the study procedure * severe metabolic acidosis (pH \< 7.25) at the time of study procedure.
Where this trial is running
Toronto, Ontario
- Unity Health Toronto - St. Michael's Hospital — Toronto, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: Laurent Brochard — Unity Health Toronto - St. Michael's Hospital
- Study coordinator: Antenor Rodrigues
- Email: Antenor.Rodrigues@unityhealth.to
- Phone: 416-864-5686
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.