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:
2025-12-26 @ 11:47 AM
Ignite Modification Date:
2025-12-26 @ 11:47 AM
NCT ID:
NCT01483716
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of OHS
* Age \>18
* BMI \> 30 kg/m2
* Chronic hypercapnia , daytime PaCO2 \>6kPa
* FEV1/FVC ≥70%
* Evidence of sleep disordered breathing on overnight studies
* Tolerated NIV \> 4hrs on 1st night during initiation of NIV
Exclusion Criteria:
* Hypercapnic respiratory failure secondary to an identifiable cause other than OHS.
* Age \<18
* Respiratory acidosis (pH \<7.35)
* Wheelchair/bedbound patients
* Cognitive impairment which would prevent the subject from complying with trial protocol
* Unstable coronary artery syndrome
* Patients postintubation or decannulation following treatment requiring acute hypercapnic respiratory failure
* Patients undergoing renal replacement therapy
* Critical peripheral vascular disease
* Disabling locomotor disability preventing participation in exercises involved in the rehabilitation programme
* Pregnancy
* Bariatric surgery planned within 3 months
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01483716
Study Brief:
Protocol Section:
NCT01483716