Susceptibility for Entrainment: Role of Ventilator Settings on the Occurrence of Reverse Triggering and Its Physiological Consequences - the SEVeRe Study
Launched by UNITY HEALTH TORONTO · Feb 27, 2024
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
The SEVeRe Study is a clinical trial that aims to understand how different settings on a mechanical ventilator can affect a phenomenon called reverse triggering in critically ill patients. Reverse triggering occurs when the ventilator mistakenly causes the patient to take breaths instead of the patient initiating their own breaths. This can lead to complications, but under certain conditions, it might also help prevent muscle weakness in the diaphragm. The researchers want to see how changing the number of breaths the ventilator delivers and the amount of air per breath affects this process and the activity of the patient’s respiratory muscles.
To participate in this study, patients must be adults who have been on a ventilator for more than 12 hours and are sedated. They should also be on a specific type of ventilator mode and not actively triggering it themselves. Participants can expect to have their ventilator settings adjusted while their breathing patterns and muscle activity are closely monitored. This information will help doctors learn more about how to improve care for patients on mechanical ventilation in the future.
Gender
ALL
Eligibility 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.
About Unity Health Toronto
Unity Health Toronto is a leading healthcare organization dedicated to providing exceptional patient care, advancing medical research, and fostering education in the field of health sciences. Comprising St. Michael's Hospital, St. Joseph's Health Centre, and Providence Healthcare, Unity Health integrates a diverse range of clinical services and innovative research initiatives. The organization is committed to improving health outcomes through collaborative partnerships and community engagement, while upholding the highest standards of ethics and integrity in its clinical trials and research endeavors. By focusing on patient-centered approaches, Unity Health Toronto aims to drive advancements in healthcare and contribute to the well-being of the communities it serves.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Toronto, Ontario, Canada
Patients applied
Trial Officials
Laurent Brochard
Principal Investigator
Unity Health Toronto - St. Michael's Hospital
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported