Recruiting

High Flow Nasal Cannula vs. Non-Invasive Ventilation

Sponsor:

Unity Health Toronto

Code:

NCT03033251

Conditions

Exacerbation Copd

Acute Respiratory Distress

Acute Hypercapnic Respiratory Failure

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

Interventions

Non Invasive Ventilation

High Flow Oxygen Cannula 50

High Flow Oxygen Cannula 30

Study Details

Brief summary:

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.

Conditions

Exacerbation Copd

Acute Respiratory Distress

Acute Hypercapnic Respiratory Failure

Study ID

NCT03033251

Start date

Sep 2, 2018

Status verified date

May, 2025

Completion date

Jul 1, 2026

Anticipated

Primary completion date

Apr 11, 2025

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. COPD exacerbation and acute hypercapnic respiratory failure with acute respiratory failure defined by

  • Respiratory acidosis (pH ≤7.35 and PaCO2 ≥45 mmHg);
  • Respiratory rate≥20 breaths/min;
  • Activation of accessory respiratory muscles;
2. Undergone at NIV or HFNC since their admission
3. English speaking
4. Adult patient with age > 40 year old.

Exclusion Criteria:

1. Severe respiratory acidosis defined by pH<7.25
2. Decreased level of consciousness (Glasgow Coma Score Scale < 11)
3. Urgent intubation required
4. Pneumothorax with pleural drainage and persistent air leak
5. Hemodynamic instability requiring vasopressors
6. Uncooperative
7. Patients with skin or chest wall or abdominal trauma (potentially worsened by placement of a surface sensor)
8. Clinical judgement of the attending physician
9. Body mass index > 40 kg/m2

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Non invasive ventilation

Patients will receive non invasive ventilation with setting decided by the attending physician.

active comparator: High Flow 50 L/min

High Flow Oxygen Cannula with a flow set at 50 L/min.

active comparator: High Flow 30 L/min

High Flow Oxygen Cannula with a flow set at 30 L/min.

Interventions

Non Invasive Ventilation

Patients will receive non invasive ventilation as a standard of care.

High Flow Oxygen Cannula 50

Patients will receive High Flow Oxygen Cannula with a flow set at 50 L/min

High Flow Oxygen Cannula 30

Patients will receive High Flow Oxygen Cannula with a flow set at 30 L/min

Primary outcome measure

  • Change in work of breathing between NIV and HFNC [ Time Frame: 30 minutes ]

Central Contacts and Locations

Central contacts

Locations

St. Michael's Hospital

Recruiting

Toronto, Ontario, Canada, M5B 1W8

Contacts

Laurent Brochard

brochardl@smh.ca

More Information

Sponsor

Unity Health Toronto

Last update posted

May 20, 2025

Last verified

May, 2025

Keywords

  • COPD exacerbation
  • Work of breathing
  • Non invasive ventilation
  • High Flow Oxygen Cannula
  • Acute Hypercapnic Respiratory Failure

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Unity Health Toronto on 2025-05-20.