High Flow Nasal Cannula Versus Non-Invasive Ventilation in Exacerbations of Chronic Obstructive Pulmonary Disease

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40+
SponsorUnity Health Toronto

About 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 does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

Severe respiratory acidosis defined by pH<7.25

Decreased level of consciousness (Glasgow Coma Score Scale < 11)

Urgent intubation required

Pneumothorax with pleural drainage and persistent air leak

Trial design

Design model

Crossover

Treatments tested in this trial

  • Non Invasive Ventilation

    Device

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

  • High Flow Oxygen Cannula 50

    Device

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

  • High Flow Oxygen Cannula 30

    Device

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

Treatment groups

30 Participants
are divided into 3 treatment groups
Group A: Non invasive ventilationActive comparator 1 intervention
Group B: High Flow 50 L/minActive comparator 1 intervention
Group C: High Flow 30 L/minActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in work of breathing between NIV and HFNC

The primary endpoint is to compare the decrease in work of breathing under HFNC to the decrease in work of breathing under NIV. The work of breathing will be assessed with diaphragm ultrasound (measurement of the diaphragm thickening fraction).

Time frame
30 minutes

Secondary outcomes

1

Change in Work of breathing between HFNC 50 and 30 L/min

The secondary endpoints include comparison of the work of breathing under HFNC (50L/min vs 30 L/min). The work of breathing will be assessed with diaphragm ultrasound (measurement of the diaphragm thickening fraction).

Time frame
30 minutes

Other outcomes

Sponsors and contacts

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