Recruiting

Observational Study

Sponsor:

Unity Health Toronto

Code:

NCT05207046

Conditions

Respiratory Support

Eligibility Criteria

Sex: All

Age: 16+

Healthy Volunteers: Not accepted

Interventions

Mechanical Ventilation

Study Details

Brief summary:

The study is designed to characterize and monitor the structure, degree of activation and function of the different respiratory muscles during mechanical ventilation after spine trauma and spinal cord injury.

Conditions

Respiratory Support

Study ID

NCT05207046

Start date

Dec 17, 2021

Status verified date

May, 2025

Completion date

Jun, 2026

Anticipated

Primary completion date

Jun, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 16+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Presence of traumatic spine lesion (with and without spinal cord injury)
  • Requiring invasive mechanical ventilation, via oro-tracheal or tracheostomy tube,
  • 16 years of age or older
  • Patient or substitute decision maker able to provide consent

Exclusion Criteria:

  • Expected withdrawal of treatments within 24 hours of screening
  • Chronic respiratory failure already treated with mechanical ventilation before the injury
  • Documented pre-existing neuromuscular diseases

Study Design

Enrollment

30 participants

Anticipated

Interventions and Outcome Measures

Arms

Patients with spinal cord injury

Patients treated with mechanical ventilation after a traumatic spine lesion with spinal cord injury

Patients with NO spinal cord injury

Patients treated with mechanical ventilation after a traumatic spine lesion with NO spinal cord injury

Interventions

Mechanical Ventilation

Patients will be assessed and measurements will be taken during controlled ventilation (most likely <72 hours of ICU admission), during partially assisted ventilation, and until spontaneous unassisted breathing is reached.

Primary outcome measure

  • Thickness and thickening fraction of the accessory muscles and their evolution over time during mechanical ventilation after spinal cord injury and spine trauma. [ Time Frame: Baseline measurements assessed ≤ 72 hours from admission and subsequent measurements assessed > 72 hours from intensive care unit admission, until spontaneous unassisted breathing is reached, up to 6 weeks from enrollment ]

Central Contacts and Locations

Central contacts

Laurent Brochard, MD, PhD

416-864-5686Laurent.Brochard@unityhealth.to

Annia Schreiber, MD

annia.schreiber@unityhealth.to

Locations

Unity Health Toronto - St. Michael's Hospital

Recruiting

Toronto, Ontario, Canada, M5B 1T8

Contacts

Laurent Brochard

416 864 5686Laurent.Brochard@unityhealth.to

More Information

Sponsor

Unity Health Toronto

Last update posted

May 20, 2025

Last verified

May, 2025

Keywords

  • Spinal cord injury
  • Trauma
  • Respiratory muscles
  • Mechanical ventilation
  • Acute respiratory failure
  • Diaphragm dysfunction

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Unity Health Toronto on 2025-05-20.