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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 40
Healthy Volunteers: f
View:

• 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;

• Undergone at NIV or HFNC since their admission

• English speaking

• Adult patient with age \> 40 year old.

Locations
Other Locations
Canada
St. Michael's Hospital
RECRUITING
Toronto
Contact Information
Primary
Laurent Brochard, MD
BrochardL@smh.ca
+1 416 864 5686
Backup
Martin Dres, MD
DresM@smh.ca
+1 416 692 7420
Time Frame
Start Date: 2018-09-02
Estimated Completion Date: 2026-07-01
Participants
Target number of participants: 30
Treatments
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.
Sponsors
Leads: Unity Health Toronto

This content was sourced from clinicaltrials.gov