Recruiting

High-Flow Nasal Cannula

Sponsor:

University Health Network, Toronto

Code:

NCT07518862

Conditions

Respiratory Failure

Heart Rate Variability (HRV)

High Flow Nasal Cannula

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

High-flow nasal cannula is a type of non-invasive respiratory support that helps patients breathe more comfortably. Because the flow is high, it can deliver more oxygen to the lungs and make breathing easier by reducing the effort needed to breathe. However, the best strategy to determine the best oxygen flow rate remains uncertain. Reducing flow rates prematurely can increase work of breathing and prolong ICU stay, while unnecessary prolongation can increase costs. Currently, evidence to guide titration is limited.

Heart rate variability is the natural variation in the time between each heartbeat. Heart rate variability reflects the level of autonomic nervous system activity in response to stress. The autonomic nervous system is the part of the nervous system that automatically controls how heart rate speeds up and slows down. When heart rate variability is higher, it indicates that the system is able to adjust to changes in the body, including stress. However, when heart rate variability is low, it indicates that the system is constrained and in a state of stress.

The VARIATION study is designed to characterize how heart rate variability goal of this observational study is to learn whether heart rate variability can serve as a marker of the appropriateness of high flow nasal cannula flow support during flow titration in patients with respiratory failure. The main question it aims to answer is:

Does heart rate variability change before other conventional respiratory signs when there are changes in respiratory function due to inadequate flow rate?

Participants already on high flow nasal cannula as part of their regular medical care will:

1. Undergo a stepwise decrease in high flow nasal cannula flow rate.
2. Be recorded continuously with electrocardiogram and electrical impedance tomography.

Conditions

Respiratory Failure

Heart Rate Variability (HRV)

High Flow Nasal Cannula

Study ID

NCT07518862

Start date

May 26, 2026

Status verified date

Jun, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Nov, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Age > 18
  • Currently receiving High-Flow Nasal Cannula Therapy

Exclusion Criteria:

  • FiO2 ≥ 90%
  • Pacemaker rhythm or presence of atrial fibrillation
  • Post-cardiac surgery patients
  • Contra-indications to electrical impedance tomography (EIT) and/or electrocardiogram (ECG) (active implantable medical device, burns, thoracic wounds limiting electrode placement)
  • Non-English-speaking

Study Design

Enrollment

20 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Change in heart rate variability during flow titration [ Time Frame: During flow titration, maximum of 1 hour and 45 minutes ]

Central Contacts and Locations

Central contacts

Locations

Toronto General Hospital

Recruiting

Toronto, Ontario, Canada, M5G 2C4

More Information

Sponsor

University Health Network, Toronto

Last update posted

Jun 18, 2026

Last verified

Jun, 2026

Keywords

  • Electrocardiogram (ECG)
  • Electrical Impedance Tomography (EIT)

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2026-06-18.