E66.2
Conditions
Interventions
Group 1: OHS patients on succesful BiPAP therapy for at least 3 months will be switched to CPAP therapy for 4-6 weeks
Sponsors
Pneumologie
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Daytime PaCO2 measured in the morning 4 hours after ventilator removal under usual BiPAP therapy and after 4-6 weeks of CPAP therapy | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. Parameters: - Lung function: Spirometry - Standardized six-minute walking test - Blood gases via capillary blood gas sampling - Nocturnal transcutaneous CO2 monitoring - Polysomnographic findings - Subjective sleep quality: Epworth Sleep Scale, Pittsburgh Sleep Quality Index - Health-related quality of life: Severe Respiratory Questionnaire - Ventilator’s software saved data (leckage, compliance) - Morning blood pressure (in mmHg) | — |
Countries
Germany
Contacts
Public ContactWolfram Windisch
Pneumologie
Outcome results
None listed