Chronic Obstructive Pulmonary Disease
Conditions
Keywords
Exacerbation of COPD, Helium/Oxygen, ICU, Non-Invasive Ventilation, Patient with known or suspected COPD, patient Admitted in an ICU, Patient presenting current exacerbation of COPD
Brief summary
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.
Detailed description
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.
Interventions
DRUGHelium/Oxygen 78%/22%
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.
DRUGAir/Oxygen
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.
Sponsors
Air Liquide Santé International
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
35 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reduction of NIV failure | 10 days (average) | Endotracheal intubation and/or death |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of invasive ventilation | 10 days (average) | — |
| Adverse events | 6 months (post-randomization) | — |
| Medico-economic parameters | 6 months | Overall costs and cost-effectiveness |
| Duration of ICU stay and duration of index hospitalisation | 10 days (average) | — |
| Duration of NIV sessions | 10 days (average) | Cumulative daily duration of NIV sessions and their number during each of the 3-day treatment period and globally |
| Time interval between the discharge of the index ICU stay and the first re-admission in ICU for severe exacerbation of COPD | 6 months (post-randomization) | — |
| Physiological and laboratory parameters | 10 days (average) | Systolic and diastolic blood pressures, heart rate, central body temperature, arterial oxygen saturation, haematology and serum biochemistry |
Countries
Belgium, France, Italy, Switzerland, Tunisia, United Kingdom
Outcome results
None listed