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High Flow Nasal Cannula vs Non-Invasive Ventilation for COPD (HiFOLD Trial)

N/A
Recruiting
Research Sponsored by Unity Health Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Activation of accessory respiratory muscles
COPD exacerbation and acute hypercapnic respiratory failure with acute respiratory failure defined by respiratory acidosis (pH ≤7.35 and PaCO2 ≥45 mmHg)
Must not have
Urgent intubation required
Pneumothorax with pleural drainage and persistent air leak
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 minutes
Awards & highlights
No Placebo-Only Group

Summary

This trial will compare the effects of two different respiratory treatments in patients with COPD. One treatment uses a mask and the other uses a simple nasal cannula. They will compare how well each treatment helps the patient's breathing and how comfortable each treatment is.

Who is the study for?
This trial is for adults over 40 with severe COPD exacerbations, who are experiencing acute respiratory failure and have already tried non-invasive ventilation (NIV) for at least an hour since admission. Participants must speak English and show signs like high respiratory rate and use of accessory muscles to breathe.
What is being tested?
The study compares two methods of assisting breathing during severe COPD exacerbations: High Flow Nasal Cannula (HFNC), which delivers a mix of air-oxygen through the nose, versus traditional Non-Invasive Ventilation (NIV) using a mask. The goal is to see if HFNC is as effective as NIV without needing a mask.
What are the potential side effects?
Potential side effects may include discomfort or irritation in the nose from the cannula, dryness or bleeding in nasal passages due to airflow, possible skin breakdown around masks used in NIV, and general discomfort associated with wearing these devices.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I use extra muscles to help me breathe.
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I have had a severe COPD flare-up with high CO2 levels and low blood pH.
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I am over 40 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I needed a breathing tube inserted urgently.
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I have a lung collapse that required a chest tube and still leaks air.
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I need medication to maintain my blood pressure.
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My consciousness level is low (GCS < 11).

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 minutes
This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 minutes for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in work of breathing between NIV and HFNC
Secondary study objectives
Change in Work of breathing between HFNC 50 and 30 L/min

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Active Control
Group I: Non invasive ventilationActive Control1 Intervention
Patients will receive non invasive ventilation with setting decided by the attending physician.
Group II: High Flow 50 L/minActive Control1 Intervention
High Flow Oxygen Cannula with a flow set at 50 L/min.
Group III: High Flow 30 L/minActive Control1 Intervention
High Flow Oxygen Cannula with a flow set at 30 L/min.

Find a Location

Who is running the clinical trial?

Unity Health TorontoLead Sponsor
556 Previous Clinical Trials
454,376 Total Patients Enrolled
~4 spots leftby Nov 2025
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