Respiratory failure MedDRA version: 9.1 Level: PT Classification code 10038695 Term: Respiratory failure
Conditions
Interventions
Trade Name: Medical Air
Product Name: Medical Air
Product Code: Medical Air
Pharmaceutical Form: Inhalation gas
Other descriptive name: AIR, MEDICINAL
Trade Name: Heliox21
Product Name: Heliox21
Prod
Sponsors
Whittington Hospital NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
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 =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: We wish to assess the practicalities of gas delivery and therapeutic benefits of Heliox21 in patients who require non-invasive ventilatory support (oxygen delivered via tightly sealed mask) following the removal of a breathing tube on the Intensive Care Unit.;Secondary Objective: We wish to assess if Heliox21 effects the number of patients who require re-insertion of the breathing tube. We wish to establish if Heliox21 effects the length of time to the removal of the tracheostomy.;Primary end point(s): Yang & Tobin 1991 conducted a prospective study of indexes predicting the outcome of trials of weaning from mechanical ventilation. They concluded rapid shallow breathing, as reflected by the f/VT ratio, was the most accurate predictor of failure, and its absence the most accurate predictor of success, in weaning patients from mechanical ventilation. We will therefore use f/VT ratio as our primary endpoint. | — |
Countries
United Kingdom
Outcome results
None listed