Actively Recruiting

Phase Not Applicable
Age: 40Years +
All Genders
NCT03033251

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

Led by Unity Health Toronto · Updated on 2025-05-20

30

Participants Needed

1

Research Sites

408 weeks

Total Duration

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AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 40Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • COPD exacerbation with acute respiratory failure defined by respiratory acidosis (pH 60;7.35 and PaCO2 60;45 mmHg)
  • Respiratory rate 60;20 breaths per minute and use of accessory respiratory muscles
  • Currently receiving non-invasive ventilation or high flow nasal cannula since admission
  • Able to speak English
  • Adult aged over 40 years
Not Eligible

You will not qualify if you...

  • Severe respiratory acidosis (pH <7.25)
  • Reduced consciousness (Glasgow Coma Score less than 11)
  • Need for urgent intubation
  • Pneumothorax with chest drainage and ongoing air leak
  • Unstable blood pressure requiring vasopressors
  • Uncooperative behavior
  • Skin, chest wall, or abdominal trauma preventing sensor use
  • Clinical judgement of attending physician excludes participation
  • Body mass index over 40 kg/m2

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

St. Michael's Hospital

Toronto, Ontario, Canada, M5B 1W8

Actively Recruiting

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Research Team

L

Laurent Brochard, MD

CONTACT

M

Martin Dres, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

TREATMENT

Number of Arms

3

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