Status:
SUSPENDED
Resting Energy Expenditure in Patients With OHS Treated With Long-term NIV
Lead Sponsor:
University Hospital, Geneva
Conditions:
Obesity-hypoventilation Syndrome
Resting Energy Expenditure
Eligibility:
All Genders
18-100 years
Brief Summary
This study aims to compare, in subjects with obesity-hypoventilation syndrome (OHS) treated by long-term non-invasive ventilation (NIV), resting energy expenditure (REE) in spontaneous breathing and u...
Detailed Description
This is an observational monocentric study in which each subject will be its own control. Patients' resting energy expenditure will be measured at rest ("spontaneous breathing" condition) and under it...
Eligibility Criteria
Inclusion
- Fulfill all criteria of obesity hypoventilation syndrome.
- Under home NIV for at least 3 months.
- Are compliant to their treatment of NIV (defined as a daily median use \> 3:30 hours).
- Have a satisfactory response to NIV (defined by a daytime PaCO2 in a sitting position \< 6.5 kPa, and a mean nocturnal SpO2 \> 90%, with less than 20% of total recording time spent with an SpO2 \< 90%).
- Are in a stable clinical condition (i.e. no episode of acute cardiac and/or respiratory failure leading to a hospitalization within the preceding 3 months).
- Are over 18 years of age.
- Are able to provide informed consent.
- Agree to participate in the study.
Exclusion
- Presents any respiratory disorder other than OHS.
- Has been under NIV less than 3 months.
- Is noncompliant (defined above) and/or intolerant to NIV.
- NIV not reaching the above-mentioned physiological targets (defined by a daytime PaCO2 in a sitting position \< 6.5 kPa, and a mean nocturnal SpO2 \> 90%, with less than 20% of total recording time spent with an SpO2 \< 90%).
- Had a recent episode of cardiac and/or respiratory failure leading to a hospitalization within the preceding 3 months.
- Is under 18 years of age.
- Presents a situation interfering with understanding of the protocol and ability to provide informed written consent (language barrier, cognitive disorder, psychiatric disturbance).
- Refuses to participate in the study.
- Is under nocturnal oxygen supplementation on NIV.
Key Trial Info
Start Date :
September 1 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2022
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04474587
Start Date
September 1 2020
End Date
December 1 2022
Last Update
November 8 2021
Active Locations (1)
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1
Geneva University Hospital
Geneva, Switzerland, 1205