The effects of helium-oxygen gas mixture (Heliox) on airway pressures in mechanically ventilated adult patients with acute lung injury - Chertsey Heliox trial

Conditions: Acute lung injury
MedDRA version: 9.1Level: LLTClassification code 10038696Term: Respiratory failure (excl neonatal)

Registration Number: EUCTR2007-000053-62-GB

Lead Sponsor: Ashford & St. Peter's Hospitals NHS Trust

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

Patients who meet the American-European Consensus Conference Criteria for ALI (acute onset, bilateral pulmonary infiltrates are present on chest X-ray) and PaO2:FiO2 < 35 on positive end-expiratory pressure (PEEP) of >=5 cm H2O.
Patients willl be enrolled within 48 hours of ALI onset
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

<18 years of age
pregnancy
participation in other trials
>48 hours of mechanical ventilation before inclusion
severe prexisting heart disease or left heart failure
unstable patients requiring high dosage of vasopressosrs (noradrenaline > 0.8 mcg/kg/min and/or dobutamine>20 mcg/kg/min)
failure to obtain written patient's next of kin assent

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To compare the effect of helium - oxygen gas mixture (Heliox) with nitrogen-oxygen gas mixture on airway pressures in mechanically ventilated patients with acute lung injury.;Secondary Objective: To compare the effect of helium - oxygen gas mixture (Heliox) with nitrogen-oxygen gas mixture on oxygenation in mechanically ventilated patients with acute lung injury.;Primary end point(s): Two primary outcome measures will be defined in terms of peak airway pressure (measured in units of cmH2O).<br>First, we will record the baseline and final (i.e. post 4 hours treatment period) peak airway pressures (measured in cmH2O).<br>Second, we will record the proportion of patients with a peak airway pressure of less then 30 cm H2O afer the 4 hours treatment period.

Secondary Outcome Measures