PtcCO2-SOH: Usefulness of Transcutaneous Capnography to Assess Residual Hypoventilation in Obesity-Hypoventilation Syndrom Treated by Non Invasive Ventilation at Home : a Prospective Study

Sponsor

Nantes University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT03572712

Collaborator

(none)

Enrollment

Location

15.2

Actual Duration (Months)

2.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Transcutaneous capnography (PtcCo2) recently showed good agreement with blood gases to assess hypercapnia. There is no study that has evaluated the benefit to realise systematically a nocturnal PtcCo2 in the follow-up of home-ventilated patient with obesity hypoventilation syndrome (OHS). The investigators will evaluate the intake bring by nocturnal transcutaneous capnography, compared to nocturnal oximetry and blood gases, to diagnose nocturnal alveolar hypoventilation in a population of patient presenting an OHS, treated by non invasive ventilation (NIV) at home .

Condition or Disease	Intervention/Treatment	Phase
Obesity Hypoventilation Syndrome	Other: No Interventional study

Detailed Description

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 Design

Study Type:

Observational

Actual Enrollment :

32 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

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 :

Aug 14, 2018

Actual Primary Completion Date :

Nov 21, 2019

Actual Study Completion Date :

Nov 21, 2019

Outcome Measures

Primary Outcome Measures

nocturnal hypoventilation [Until 37 days]
Nocturnal PtcCo2 > 49 mmHg more than 10% of sleeping time

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Obesity Hypoventilation Syndrom defined by a diurnal PaCo2> 45 mmHg, in stable conditions, in a patient presenting an obesity (BMI > 30 kg/m²)
treated by non invasive ventilation since at least 3 weeks, and seen in follow-up consultation

Exclusion Criteria:

minors
refusal to participate
under guardianship or trusteeship
pregnant woman
other etiology of hypoventilation : copd, kyphoscoliosis, neuromuscular disorders, diaphragmatic pathology