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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
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital

Study Description
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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
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
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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 : August 14, 2018
Actual Primary Completion Date : November 21, 2019
Actual Study Completion Date : November 21, 2019
Groups and Cohorts
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Intervention Details:
  • Other: No Interventional study
    every patient will be monitored with a blood gase, a nocturnal oximetry and a transcutaneous capnography

Outcome Measures
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Primary Outcome Measures :
  1. nocturnal hypoventilation [ Time Frame: Until 37 days ]
    Nocturnal PtcCo2 > 49 mmHg more than 10% of sleeping time


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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France
Nantes University Hospital
Nantes, France, 44093
Sponsors and Collaborators
Nantes University Hospital
More Information
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Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT03572712    
Other Study ID Numbers: RC18_0017
First Posted: June 28, 2018    Key Record Dates
Last Update Posted: December 24, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nantes University Hospital:
Obesity Hypoventilation Syndrome
Non Invasive Ventilation
Transcutaneous capnography
Additional relevant MeSH terms:
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Obesity Hypoventilation Syndrome
Obesity
Hypoventilation
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Respiratory Insufficiency
Respiration Disorders
 Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Sleep Apnea, Obstructive
Sleep Apnea Syndromes
Apnea
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases