Usefulness of Transcutaneous Capnography to Assess Residual Hypoventilation in Obesity-Hypoventilation Syndrom Treated by Non Invasive Ventilation at Home : a Prospective Study (PtcCO2-SOH)
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|ClinicalTrials.gov Identifier: NCT03572712|
Recruitment Status : Completed
First Posted : June 28, 2018
Last Update Posted : December 24, 2020
|Condition or disease||Intervention/treatment|
|Obesity Hypoventilation Syndrome||Other: No Interventional study|
Patients will be evaluated once a year in consultation with a blood gases, and then a nocturnal recording at home including a transcutaneous capnography and an oximetry.
Some data will be registered too : cardiovascular and neurological comorbidities, diabetes mellitus, treatment, parameters of the non-invasive ventilation, duration of compliance and apnea-hypopnea index (if available).
The investigators will perform a sequential analysis of nocturnal hypoventilation with first blood gases, then nocturnal oxymetry and to finish nocturnal PtcCo2. It will allow us to determine if PtcCo2 catch up some nocturnal hypoventilation, undetected by the first two exams.
The investigators plan that the study will last 18 months. The analysis will be descriptive. Quantitative variables will be described with mean, standard deviation, minimum, maximum and median. Quantitative variables are presented with number and percentage.
Comparison of blood gas / oximetry association with blood gas / oximetry / transcutaneous capnography using a McNemar test
|Study Type :||Observational|
|Actual Enrollment :||32 participants|
|Official Title:||Usefulness of Transcutaneous Capnography to Assess Residual Hypoventilation in Obesity-Hypoventilation Syndrom Treated by Non Invasive Ventilation at Home : a Prospective Study|
|Actual Study Start Date :||August 14, 2018|
|Actual Primary Completion Date :||November 21, 2019|
|Actual Study Completion Date :||November 21, 2019|
- Other: No Interventional study
every patient will be monitored with a blood gase, a nocturnal oximetry and a transcutaneous capnography
- nocturnal hypoventilation [ Time Frame: Until 37 days ]Nocturnal PtcCo2 > 49 mmHg more than 10% of sleeping time
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03572712
|Nantes University Hospital|
|Nantes, France, 44093|