Actively Recruiting
High Flow Nasal Cannula Versus Non-Invasive Ventilation in Exacerbations of Chronic Obstructive Pulmonary Disease and Hypercapnic Respiratory Failure
Led by Unity Health Toronto · Updated on 2025-05-20
30
Participants Needed
1
Research Sites
63 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Chronic obstructive lung disease (COPD) is a disabling condition often caused by long-term tobacco smoke exposure, affecting millions worldwide and marked by episodes of worsening symptoms called exacerbations. These exacerbations can cause severe breathlessness requiring hospitalizations and sometimes admission to an Intensive Care Unit (ICU) for respiratory support. This research evaluates a newer technique called High Flow Nasal Cannula (HFNC) compared to the standard non-invasive ventilation (NIV) in patients with severe COPD exacerbations and hypercapnic respiratory failure. The study aims to determine if HFNC is not inferior to NIV in helping with breathing effort and if it offers better patient comfort since it does not require a mask. Participants will receive both HFNC and NIV treatments during the study. HFNC will be delivered at flow rates of 30 and 50 liters per minute in random order, with temperature settings adjusted for comfort. NIV settings will be managed by respiratory therapists following standard care and remain constant during testing. Each device will be applied for up to 30 minutes, with a 5-minute oxygen therapy washout between conditions. The entire procedure lasts up to 3 hours and takes place in a medical-surgical ICU setting. No additional follow-up occurs after the study. During the study, participants will be monitored continuously with pulse oximetry and transcutaneous CO2 measurements. Ultrasound exams will assess diaphragm and other respiratory muscle thickness and activity at specific time points. Researchers will record breathing effort and muscle activity under spontaneous breathing and during each ventilation support method. The primary outcome measures the change in work of breathing between NIV and HFNC after 30 minutes. Secondary outcomes compare work of breathing between the two HFNC flow rates. Safety and tolerance are closely observed, and the study ends promptly if clinical intolerance occurs.
CONDITIONS
Brief Title
High Flow Nasal Cannula Versus Non-Invasive Ventilation in Exacerbations of Chronic Obstructive Pulmonary Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- COPD exacerbation with acute hypercapnic respiratory failure defined by respiratory acidosis (pH ≤ 7.35 and PaCO2 ≥ 45 mmHg), respiratory rate ≥ 20 breaths/min, and use of accessory respiratory muscles
- Have used non-invasive ventilation (NIV) or high flow nasal cannula (HFNC) since admission
- Able to speak and understand English
- Adult aged over 40 years
You will not qualify if you...
- Severe respiratory acidosis with pH less than 7.25
- Decreased level of consciousness (Glasgow Coma Score less than 11)
- Require urgent intubation
- Pneumothorax with pleural drainage and persistent air leak
- Hemodynamic instability requiring vasopressors
- Uncooperative behavior
- Skin, chest wall, or abdominal trauma that could be worsened by sensor placement
- Clinical judgment by attending physician
- Body mass index over 40 kg/m2
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 3 hours
Participants will be consecutively ventilated with high flow nasal cannula (HFNC) at 30 and 50 L/min and non-invasive ventilation (NIV) in a random order. Each device will be applied for up to 30 minutes with washout periods of oxygen therapy between sessions while various respiratory measurements are taken.
1 in-person visit during ICU stay
Trial Site Locations
Total: 1 location
1
St. Michael's Hospital
Toronto, Ontario, Canada, M5B 1W8
Actively Recruiting
Research Team
L
Laurent Brochard, MD
M
Martin Dres, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
3
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here