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 - ECHO ICU trial
- 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.
- Registration Number
- EUCTR2008-006173-33-GB
- Lead Sponsor
- Air Liquide Santé International
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 670
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
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,
11.h)Extreme obesity defined by a Body Mass Index (BMI) > 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 < 1 month),
14)Patient with severe concomitant chronic systemic disease: renal failure (creatinine > 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.
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 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