Status:
UNKNOWN
Physiological Response to Heliox21 and Air O2
Lead Sponsor:
University College, London
Conditions:
Respiratory Insufficiency
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 patie...
Detailed Description
Failure to wean from mechanical ventilatory support occurs when the magnitude of respiratory system loading exceeds its capacity to respond. Extubation success depends on the condition being resolved ...
Eligibility Criteria
Inclusion
- Adults aged ≥ 18 years
- Males
- Females
- 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
- Age \< 18 years
- Patient/legal representative refusal or inability to consent
- Adults with learning disabilities/ dementia
- Any contraindication to non-invasive ventilation:
- Inability to use mask (trauma/surgery) Excessive secretions Haemodynamic instability/life threatening arrhythmia
- 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
- Patients already enrolled in an interventional
- Females known to be pregnant
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2013
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT01498432
Start Date
January 1 2012
End Date
April 1 2013
Last Update
December 23 2011
Active Locations (1)
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1
Whittington Hospital NHS Trust
London, United Kingdom, N19 5NF