Prospective randomised cross over comparison on the physiological response to non-invasive ventilation using either Air O2 or Heliox21 - Physiological response to Heliox21 and Air O2

• Conditions: Respiratory failure; MedDRA version: 9.1Level: PTClassification code 10038695Term: Respiratory failure

• Registration Number: EUCTR2007-004851-12-GB
• Lead Sponsor: Whittington Hospital NHS Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-12-13
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Adults aged =18 years
2. Males
3. Females
4. Any patient who is ventilated for = 5 days and/or has a tracheostomy to assist weaning from mechanical ventilation who has one or more of following risk factors suggesting that they are at risk of needing post extubation CPAP/BiPAP/NIV
5. BMI >28
6. Underlying respiratory disease
7. SpO2 <95% on 35% FiO2
8. Smoker

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

1. Age < 18 years
2. Patient/next of kin refusal/inability to consent
3. Adults with learning disabilities/dementia
4. Any contraindication to non-invasive ventilation
5. Inability to use mask (trauma/surgery)
6. Excessive secretions
7. Haemodynamic instability/life threatening arrhythmia
8. High risk of aspiration
9. Impaired mental status (Detained under the Mental Health Act)
10. Un-co-operative/agitated patient
11. Life threatening refractory hypoxemia
12. Undrained pneumothorax
13. Bullae on X-Ray
14. Recent upper GI anastamosis
15. Patients already enrolled in an interventional study

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified