Obesity Hypoventilation Syndrome
Conditions
Keywords
Obesity Hypoventilation Syndrome, Prevalence, Bicarbonate
Brief summary
Rationale of the BIO-OHS study (Prevalence of Obesity Hypoventilation Syndrome): The overall prevalence of Obesity Hypoventilation Syndrome (OHS) has never been directly assessed in the general population. Actually, this prevalence has been assessed in patients referred to sleep clinics with a potential diagnosis of sleep-disordered breathing or in patients already diagnosed with sleep apnea. The purpose of this study is to determine the prevalence of Obesity Hypoventilation syndrome in obese patients referred to clinical laboratories for regular follow-up medical analysis.
Detailed description
No additional description
Interventions
PROCEDUREBlood test analysis in the clinical labs
for specific measurement of plasmatic bicarbonate
PROCEDUREPneumologist consult to establish the diagnosis of OHS
complete respiratory check-up: Arterial blood gases analysis, spirometry, anthropometry, polygraphy or polysomnography. Medical history, previous treatments.
Sponsors
AGIR à Dom
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 years old ans more * BMI over 30 kg/M2 * Stable state (respiratory, metabolic and cardio-vascular) for the last 2 months * Addressed to a clinical labs for a blood check-up whatever the prescription
Exclusion criteria
* No social security * Non cooperative patient, as judged by the investigator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Prevalence of Obesity Hypoventilation Syndrome (OHS) in obese subjects referred to clinical laboratories for regular blood test analysis. | From date of inclusion until the end of the study currently planned (up to 2 years) | OHS prevalence, validated by arterial blood gases analysis, will be assessed by the percentage of patients with OHS among all patients included in the study |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity and specificity of plasmatic [HCO3-] to detect OHS | From date of inclusion to the end of the study currently planned (2 years) | A ROC curve will determine if the threshold of 27 mmol/L has the best diagnostic value. Decision trees will show if the diagnostic value of plasmatic \[HCO3-\]could be optimized by a combination with other clinical parameters. |
| Prevalence of metabolic and cardiovascular comorbidities in patients with OHS | From date of inclusion to the end of the study currently planned (2 years) | Prevalence will be estimated by the percentage and the confidence interval. Prevalences of metabolic and cardiovascular comorbidities among patients with OHS and without OHS will be compared by a KHI-2 test or Fisher Exact depends on the theorical number. |
| To determine which medical specialties referred patients with OHS to clinical labs | From date of inclusion to the end of the study currently planned (2 years) | estimated by percentage |
| Incidence of serious health events at 1 and 2-year follow-up | From time of OHS diagnostic to 1 and 2-year follow-up | Cardiovascular, metabolic and respiratory events (measured by percentages in OHS group and non-OHS group) will be compared by logistic regressions. |
Countries
France
Outcome results
None listed