Efficacy of Helium/Oxygen Compared to Air/Oxygen in Severe Exacerbation of Chronic Obstructive Pulmonary Disease (COPD)

Phase 3TerminatedNCT01155310

Air Liquide Santé International446 enrolled

Overview

The primary objective of the study is to evaluate the efficacy of Helium/Oxygen (He/O2) 78%/22% compared to a conventional Air/O2 mixture in reducing endotracheal intubation rate and mortality in patients with severe hypercapnic exacerbations of Chronic Obstructive Pulmonary Disease (COPD) during their index Intensive/Intermediate Care Unit (ICU) stay.

Patients eligible for this study are critically ill patients with COPD admitted in Intensive Care Unit for an exacerbation of their chronic disease with hypercapnic acute respiratory failure. The patients will receive an Helium/Oxygen mixture or an Air/Oxygen mixture for a maximum of 72 hours during Non-Invasive Ventilation (NIV) and NIV-free sessions. During NIV sessions, gas mixtures will be administered using a ventilator suitable for NIV with either He/O2 or Air/O2 and a NIV facemask. Patients will be followed until hospital discharge and then contacted by phone up to the 6th month after randomization.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

446

Conditions

Chronic Obstructive Pulmonary Disease

Interventions

Helium/Oxygen 78%/22%DRUG

The Helium/Oxygen mixture will be administered during NIV and NIV-free sessions for a maximum of 72 hours using study dedicated devices. Patients will then receive the Air/Oxygen mixture with usual devices.

Air/OxygenDRUG

Eligibility

Sex: ALLMin age: 35 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patient with known or suspected COPD * Patient presenting current exacerbation of COPD with hypercapnic acute respiratory failure * Patient eligible for Non-Invasive Ventilation (NIV) * Patient admitted in an ICU Exclusion Criteria: * Patient who had lung transplant * Patient having a contraindication to NIV * Patient with tracheostomy * Patient requiring Oxygen flow rate \> 6 L/min or Inspired Oxygen Fraction (FIO2) \> 0.50 * Patient admitted in the ICU for more than 24 hours and/or having received NIV in ICU for more than 6 hours (in total) for the current exacerbation of COPD

Locations (16)

Cliniques Universitaires Saint Luc

Brussels, Belgium

Les Cliniques Universitaires UCL Mont Godinne

Yvoir, Belgium

Outcomes

Primary Outcomes

Reduction of NIV failure

Endotracheal intubation and/or death

Time frame: 10 days (average)

Secondary Outcomes

Duration of ICU stay and duration of index hospitalisation

Time frame: 10 days (average)

Duration of invasive ventilation

Time frame: 10 days (average)

Adverse events

Time frame: 6 months (post-randomization)

Medico-economic parameters

Overall costs and cost-effectiveness

Time frame: 6 months

Physiological and laboratory parameters

Systolic and diastolic blood pressures, heart rate, central body temperature, arterial oxygen saturation, haematology and serum biochemistry

Time frame: 10 days (average)

Duration of NIV sessions

Cumulative daily duration of NIV sessions and their number during each of the 3-day treatment period and globally

Time frame: 10 days (average)

Time interval between the discharge of the index ICU stay and the first re-admission in ICU for severe exacerbation of COPD

Time frame: 6 months (post-randomization)

Data from ClinicalTrials.gov

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