Out of hospital care of OHS patients receiving non-invasive ventilation - a randomised controlled trial (OHONIV)

Not Applicable

• Conditions: E66.2; J96.1; Extreme obesity with alveolar hypoventilation; Chronic respiratory failure

• Registration Number: DRKS00028287
• Lead Sponsor: Kliniken der Stadt Köln gGmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-02-25
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Obesity hypoventilation syndrome
- Definition according to the ATS Guidelines
- NIV therapy for at least 3 months
- Signed informed consent
- Patient age = 18 years

Exclusion Criteria

- Patient age < 18 years
- Mental retardation
- Missing informed consent

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Health-related quality of life measured by Severe Respiratory Insufficiency Questionnair (SRI) after 12 months

Secondary Outcome Measures

Name	Time	Method
1. descriptive analysis of the demographic data and the health care situation <br>2. identification of influencing factors by evaluating the cost analysis, ventilation quality on the basis of the ABG on the day, therapy adherence and mortality<br>3. evaluation of the S3 NIV with regard to quality of life and NIV-related symptoms.