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 volunteersQualifiers
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
Crossover
Treatments tested in this trial
Non Invasive Ventilation
DevicePatients will receive non invasive ventilation as a standard of care.
High Flow Oxygen Cannula 50
DevicePatients will receive High Flow Oxygen Cannula with a flow set at 50 L/min
High Flow Oxygen Cannula 30
DevicePatients will receive High Flow Oxygen Cannula with a flow set at 30 L/min
Treatment groups
Trial outcomes
Primary outcomes
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).
Secondary outcomes
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).
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