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

NCT03033251 | Recruiting

• 1 other identifier: REB# 16-389
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

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).

  30 minutes

Secondary Outcomes (1)

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

  30 minutes

Study Arms (3)

Non invasive ventilation

ACTIVE COMPARATOR

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

Device: Non Invasive Ventilation

High Flow 50 L/min

ACTIVE COMPARATOR

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

Device: High Flow Oxygen Cannula 50

High Flow 30 L/min

ACTIVE COMPARATOR

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

Device: High Flow Oxygen Cannula 30

Interventions

Non Invasive Ventilation DEVICE

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

Also known as: Standard of Care

Non invasive ventilation

High Flow Oxygen Cannula 50 DEVICE

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

Also known as: HFNO 50

High Flow 50 L/min

High Flow Oxygen Cannula 30 DEVICE

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

Also known as: HFNO 30

High Flow 30 L/min

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• Hemodynamic instability requiring vasopressors
• Uncooperative
• Patients with skin or chest wall or abdominal trauma (potentially worsened by placement of a surface sensor)
• Clinical judgement of the attending physician
• Body mass index \> 40 kg/m2

Sponsors & Collaborators

• Unity Health Toronto: lead

Study Sites (1)

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

RECRUITING

MeSH Terms

Conditions

Acute Lung Injury; Respiratory Insufficiency

Interventions

Noninvasive Ventilation

Condition Hierarchy (Ancestors)

Lung Injury; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Intervention Hierarchy (Ancestors)

Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Central Study Contacts

Laurent Brochard, MD

CONTACT

+1 416 864 5686; BrochardL@smh.ca

Martin Dres, MD

CONTACT

+1 416 692 7420; DresM@smh.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will receive 2 treatments (non invasive ventilation and high flow nasal cannula). The high flow nasal cannula will be applied with 2 flows (50 L/min and 30 L/min). The order of application of the 2 high flow sequences will be randomized (sealed opaque enveloppes).

Study Record Dates

• First Submitted: January 19, 2017
• First Posted: January 26, 2017
• Study Start: September 2, 2018
• Primary Completion: April 11, 2025
• Study Completion (Estimated): July 1, 2026
• Last Updated: May 20, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)