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RECRUITINGINTERVENTIONAL

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

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

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.

Who May Be Eligible (Plain English)

Who May Qualify: 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. Who Should NOT Join This Trial: 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

DEVICE

Non Invasive Ventilation

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

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High Flow Oxygen Cannula 50

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

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High Flow Oxygen Cannula 30

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

Locations (1)

St. Michael's Hospital
Toronto, Ontario, Canada