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

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Unity Health Toronto

No Placebo Group

Trial Summary

What is the purpose of this trial?Chronic obstructive lung disease is a disabling disease that affects people usually after several years of smoke tobacco exposure and affects millions of patients worldwide. The disease is marked by multiples episode of worsening, termed exacerbations necessitating frequent hospitalizations. During these exacerbations, patients present breathless, and in the most severe cases, are admitted to an Intensive Care Unit (ICU) for respiratory assistance. Currently, respiratory assistance is provided by a ventilator via a oronasal mask (referred to non-invasive ventilation, NIV), that helps patients to cope with their breathless. The mask is not always well tolerated and the ventilator sessions are delivered intermittently. In the past decade, a new technique that provides air-oxygen with high flow has been developed. This technique, called High Flow via Nasal Cannula (HFNC) can deliver from 21 to 100% heated and humidified air-oxygen at a high flow of gas via simple nasal cannula. Recent studies have shown that the technique is very efficient to treat patients presenting with acute respiratory failure who don't have any underlying chronic pulmonary disease. Whether the technique would be also efficient in patients with COLD presenting with severe exacerbations has not yet been demonstrated. Since HFNC does not require any mask, it is thought that the comfort of the patient would be much better in comparison to NIV and could potentially help to treat many patients with the disease. The objective of the present study is to study the physiological effect of HFNC as compared to NIV in patients with severe exacerbations of COPD and to show that it is non-inferior to NIV.

Eligibility Criteria

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.

Inclusion Criteria

English speaking

Undergone at NIV or HFNC since their admission

Respiratory rate≥20 breaths/min

+3 more

Exclusion Criteria

Uncooperative

Patients with skin or chest wall or abdominal trauma (potentially worsened by placement of a surface sensor)

Body mass index > 40 kg/m2

+6 more

Participant Groups

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.

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.