Patients eligible for this study are critically ill patients with COPD admitted in ICU for an exacerbation of their chronic disease with hypercapnic acute respiratory failure. MedDRA version: 12.0 Level: LLT Classification code 10009033 Term: Chronic obstructive pulmonary disease
Conditions
Interventions
Trade Name: Oxygene Medical Air Liquide Santé France
Product Name: Medical Oxygen
Pharmaceutical Form: Inhalation gas
INN or Proposed INN: Oxygen
CAS Number: 7782-44-7
Other descriptive name: Medical
Sponsors
Air Liquide
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Male or female patient, aged = 35 years, 2) Patient with known or suspected COPD, 3) Patient presenting current exacerbation of COPD with hypercapnic acute respiratory failure, 4) Patient presenting the following criteria for starting Non-Invasive Ventilation (NIV) sessions: 4.a) PaCO2 ³45 mmHg (6.0 kPa), And at least 2 of the following: 4.b) Respiration rate = 25 breaths per minute, 4.c) PaO2 = 50 mmHg (6.7 kPa) or SpO2 = 90% on room air, 4.d) Arterial pH = 7.35, 5) Patient admitted in an ICU, 6) Written informed consent signed and dated by the patient or next of kin after full explanation of the study by the investigator prior to participation, Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 7) Patient previously randomised in the study, 8) Patient admitted in the ICU for more than 24 hours and/or having received Non-Invasive Ventilation (NIV) in ICU for more than 6 hours (in total) for the current exacerbation of COPD, 9) Patient with tracheostomy, 10) Patient who had lung transplant, 11) Patient having a contraindication to NIV: 11.a) Respiratory arrest, severe acute respiratory failure with high probability of imminent intubation, 11.b) Sustained haemodynamic instability (hypotension with systolic blood pressure 35, 12) Patient requiring oxygen flow rate > 6 L/min or FIO2 > 0.50, 13) Patient with acute respiratory failure believed to be attributable to a current significant chronic disease other than COPD (asthma, significant bronchiectasis, cystic fibrosis, sarcoidosis, lung fibrosis, kyphoskoliosis, neuromuscular disease, …), or to severe pulmonary embolism, extensive pneumonia or pneumothorax (either currently documented and not drained at selection or recent episode 150 mmol/L), any chronic disease other than COPD with a limited probability of survival (< 6 months), 15) Pregnant or lactating woman, 16) Patient with known or suspected allergy to facemask compounds, 17) Patient who has received another investigational drug within 30 days prior to selection.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: - To assess short term and long term efficacy criteria - To assess the safety of the administration of He/O2 78%/22% in ICU - To evaluate medico-economic data ;Primary end point(s): NIV failure (i.e., endotracheal intubation and/or death) during the index ICU stay for each randomised patient;Main Objective: To evaluate the efficacy of Helium/Oxygen 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 | — |
Countries
Belgium, France, Germany, Italy, United Kingdom
Outcome results
None listed