Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:35 PM
Ignite Modification Date:
2025-12-24 @ 9:35 PM
NCT ID:
NCT01498432
Eligibility 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01498432
Study Brief:
Protocol Section:
NCT01498432