Recruiting

Observational Study

Sponsor:

Unity Health Toronto

Code:

NCT06716463

Conditions

Ventilatory Failure

Hypoxemic Respiratory Failure

Weaning Failure

Respiratory

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

The goal of this observational study is to assess the potential non-invasive tools (e.g. regional ventilation, respiratory muscle response, lung mechanic's parameters) to identify the risk of failure when using high flow nasal cannula (HFNC) or non-invasive ventilation (NIV).

The main question, it aims to answer is:

Does abnormal regional ventilation could predict HFNC or NIV failure?

Conditions

Ventilatory Failure

Hypoxemic Respiratory Failure

Weaning Failure

Respiratory

Study ID

NCT06716463

Start date

Jan 27, 2025

Status verified date

May, 2025

Completion date

Jun, 2025

Anticipated

Primary completion date

Jun, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Age of ≥ 18 years
  • Using NIV or HFNC anywhere in the hospital

Exclusion Criteria:

  • Chronic CO2 retention
  • Neuromuscular disorder
  • Requiring home NIV (CPAP or BIPAP)
  • Tracheostomy
  • Contraindication to EIT placement: pacemaker/defibrillator implantation, burns at the area of EIT placement

Study Design

Enrollment

80 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Difference in regional ventilation distribution (%) [ Time Frame: The parameter is measured at the time of enrolment. Failure of HFNC or NIV is adjudicated at 7 days. ]

Central Contacts and Locations

Locations

St. Michael's Hospital

Recruiting

Toronto, Ontario, Canada, M5B 1W8

Contacts

Laurent J. Brochard, MD

416-864-6060laurent.brochard@unityhealth.to

More Information

Sponsor

Unity Health Toronto

Last update posted

May 20, 2025

Last verified

May, 2025

Keywords

  • Electrical impedance tomography
  • High flow nasal cannula
  • Non-invasive ventilation
  • Diaphragm
  • Weaning failure
  • Post-extubation
  • Hypoxemic respiratory failure

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.