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Non invasive ventilation for Acute Respiratory Failure (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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 minutes
Awards & highlights

HiFOLD Trial 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.Check my eligibility
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.See study design
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.

HiFOLD Trial 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.

HiFOLD Trial 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

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

HiFOLD 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
535 Previous Clinical Trials
447,053 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~1 spots leftby Jul 2024