Obesity hypoventilation syndrome treated with non-invasive ventilation: can we switch to CPAP?

Not Applicable

• Conditions: E66.2; Extreme obesity with alveolar hypoventilation

• Registration Number: DRKS00008943
• Lead Sponsor: Pneumologie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-07-29
• Study Completion: 2016-08-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 43

Inclusion Criteria

• Stable OHS patients on BiPAP therapy for at least 3 months considered successful as determined by diurnal PaCO2 =45 mmHg and less than 20% of total sleep time with saturation <90%.
• Initial OHS diagnosis before BiPAP implementation must fulfill the conventional diagnostic criteria: coexistence of obesity (BMI =30 kg/m²) and daytime hypercapnia (PaCO2 =45 mmHg) after excluding other hypoventilation conditions.
• Age = 18 years

Exclusion Criteria

• FEV1/FVC% ratio <70% plus FEV1 <50%
• OHS patients on BiPAP therapy with unstable condition (= 2 hospitalizations for acute respiratory failure in the last year)
• Daytime PaCO2 = 45mmHg despite established BiPAP therapy
• Psychological incapacity to perform questionnaires
• Refusal to participate in the study

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Daytime PaCO2 measured in the morning 4 hours after ventilator removal under usual BiPAP therapy and after 4-6 weeks of CPAP therapy

Secondary Outcome Measures

Name	Time	Method
Patients will be evaluated for their baseline data during the day and night under usual BiPAP therapy. The second measurments evaluation will take place after a 4 to 6 week period of the switch to CPAP-therapy. <br>Parameters: <br>- Lung function: Spirometry<br>- Standardized six-minute walking test <br>- Blood gases via capillary blood gas sampling<br>- Nocturnal transcutaneous CO2 monitoring<br>- Polysomnographic findings<br>- Subjective sleep quality: Epworth Sleep Scale, Pittsburgh Sleep Quality Index<br>- Health-related quality of life: Severe Respiratory Questionnaire <br>- Ventilator’s software saved data (leckage, compliance)<br>- Morning blood pressure (in mmHg)<br>