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Search / Trial NCT06293976

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

Hypnotics And Sedatives Respiratory Muscles

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.

Locations

Toronto, Ontario, Canada

Patients applied

0 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