Acute lung injury MedDRA version: 9.1 Level: LLT Classification code 10038696 Term: Respiratory failure (excl neonatal)
Conditions
Interventions
Trade Name: Heliox21
Product Name: Heliox21
Product Code: Heliox21
Pharmaceutical Form: Inhalation gas
Trade Name: Medical Air
Product Name: Medical Air
Product Code: Medical Air
Pharmaceutical Form:
Sponsors
Ashford & St. Peter's Hospitals NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
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 =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
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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). First, we will record the baseline and final (i.e. post 4 hours treatment period) peak airway pressures (measured in cmH2O). 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. | — |
Countries
United Kingdom
Outcome results
None listed