Physiological Response to Heliox21 and Air O2

• Status: Unknown status
• Trial end date: 2013-04-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a non-commercial study to explore the use of Heliox21 in a new patient cohort. The fundamental aim is to assess the therapeutic benefits of Heliox21 and practicalities of gas delivery in patients who require non-invasive ventilatory support following extubation on the Intensive Care Unit. Thus, the investigators aim to extend our knowledge of the potential role for Heliox21 in the post-extubation environment of the Intensive Care Unit. The purpose of this study is to answer a specific, clinically relevant question. That is whether Heliox21 helps to reduce the effort of breathing in the period following withdrawal of mechanically assisted ventilation in patients on the intensive care unit.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University College, London

Criteria

Inclusion Criteria:

1. Adults aged ≥ 18 years

2. Males

3. Females

4. Any patient requiring mechanical ventilation for 5 days or more 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 continuous positive airway pressure (CPAP), BiLevel positive airway pressure (BiPAP) or non-invasive ventilation (NIV):

• BMI of 28 or more

• Underlying respiratory disease (including asthma, COPD and bronchiectasis) as documented in medical notes for this current hospital admission.

• SpO2 < 95% on 35% FiO2 or more

• Smoker

• Ex-smoker less than 12 months

• Ex-smoker 10 pack year* or more history * Pack year = (Number of cigarettes per day X Number of years) ÷ 20

Exclusion Criteria:

1. Age < 18 years

2. Patient/legal representative refusal or inability to consent

3. Adults with learning disabilities/ dementia

4. Any contraindication to non-invasive ventilation:

Inability to use mask (trauma/surgery) Excessive secretions Haemodynamic instability/life threatening arrhythmia

5. High risk of aspiration:

• Impaired mental status (Detained under the Mental Health Act)

• Un-co-operative/agitated patient

• Life threatening refractory hypoxemia

• Undrained pneumothorax

• Bullae on X-Ray

• Recent upper GI anastamosis

6. Patients already enrolled in an interventional

7. Females known to be pregnant