An international Phase III randomised trial comparing in severe Exacerbations of Chronic obstructive pulmonary disease the efficacy of Helium/Oxygen versus Air/Oxygen administered during spontaneous breathing and intermittent non-invasive ventilation. The E.C.H.O.ICU trial. - E.C.H.O. ICU Trial

Phase 1

Conditions: 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: 14.1Level: PTClassification code 10009033Term: Chronic obstructive pulmonary diseaseSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

Registration Number: EUCTR2008-006173-33-BE

Lead Sponsor: Air Liquide Santé International

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 670

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 = 45 mmHg (6.0 kPa), AND arterial pH = 7.35,
And at least 1 of the following:
4.b) Respiration rate = 25 breaths per minute,
or
4.c) PaO2 = 50 mmHg (6.7 kPa) or SaO2 = 90% or SpO2 = 90%,
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

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 < 90 mmHg despite volume loading and/or administration of vasopressor treatment),
11.c) Coma, impaired consciousness, uncooperative patient, neurologic instability not due to acute hypercapnia (e.g., stroke, substance abuse or withdrawal, …),
11.d) Shock or multiple organ failure syndrome,
11.e) Severe ventricular rhythm disorders,
11.f) Uncontrollable vomiting,
11.g) Recent facial or gastro-oesophageal surgery, severe craniofacial trauma,
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 < 1 month),
14) Patient with severe concomitant chronic systemic disease 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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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;Secondary Objective: - To assess short term and long term efficacy criteria <br>- To assess the safety of the administration of the He/O2 78%/22% in ICU<br>- To evaluate medico-economic data<br>;Primary end point(s): NIV failure (i.e., endotracheal intubation and/or death) during the index ICU stay for each randomised patient

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Duration of index ICU stay and duration of index hospitalisation<br>Time interval between the discharge of the index ICU stay and the first re-admission in ICU for severe exacerbation of COPD<br>Duration of NIV sessions during the index ICU stay<br>Duration of invasive ventilation<br>Physiological and laboratory parameters<br>Adverse events<br>Medico-economic parameters

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