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

NCT03572712 | Completed

• 1 other identifier: RC18_0017
• Study Type: observational
• Target: 32
• Locations: 1 country
• Sites: 1

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 .

Conditions

Obesity Hypoventilation Syndrome

Keywords

Obesity Hypoventilation Syndrome; Non Invasive Ventilation; Transcutaneous capnography

Outcome Measures

Primary Outcomes (1)

• nocturnal hypoventilation

  Nocturnal PtcCo2 \> 49 mmHg more than 10% of sleeping time

  Until 37 days

Interventions

No Interventional study OTHER

every patient will be monitored with a blood gase, a nocturnal oximetry and a transcutaneous capnography

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (1)

Nantes University Hospital

Nantes, 44093, France

Location

MeSH Terms

Conditions

Obesity Hypoventilation Syndrome

Condition Hierarchy (Ancestors)

Sleep Apnea, Obstructive; Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Hypoventilation; Respiratory Insufficiency; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2018
• First Posted: June 28, 2018
• Study Start: August 14, 2018
• Primary Completion: November 21, 2019
• Study Completion: November 21, 2019
• Last Updated: December 24, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)