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

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 .

Study Overview

• Status: Completed
• Conditions: Obesity Hypoventilation Syndrome
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 32

Contacts and Locations

Study Locations

• France
  • Nantes, France, 44093
    • Nantes University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The pneumology department at Nantes University Hospital follows approximately 400 patients treated by non-invasive ventilation, 250 of whom have SOH The investigators plan to include 150 patients in the active patient line followed at Nantes University Hospital, which will make it possible to obtain the number of patients necessary to obtain satisfactory power while taking into account the fact that a certain number of transcutaneous capnographies will not be conclusive.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
nocturnal hypoventilation	Nocturnal PtcCo2 > 49 mmHg more than 10% of sleeping time	Until 37 days

Collaborators and Investigators

• Sponsor: Nantes University Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 14, 2018
• Primary Completion (ACTUAL): November 21, 2019
• Study Completion (ACTUAL): November 21, 2019

Study Registration Dates

• First Submitted: June 13, 2018
• First Submitted That Met QC Criteria: June 27, 2018
• First Posted (ACTUAL): June 28, 2018

Study Record Updates

• Last Update Posted (ACTUAL): December 24, 2020
• Last Update Submitted That Met QC Criteria: December 22, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: Non Invasive Ventilation; Obesity Hypoventilation Syndrome; Transcutaneous capnography
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Overnutrition; Nutrition Disorders; Overweight; Body Weight; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Respiratory Insufficiency; Sleep Apnea, Obstructive; Obesity; Hypoventilation; Obesity Hypoventilation Syndrome
• Other Study ID Numbers: RC18_0017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No