Concordance Between ETCO2, PTCO2 and PaCO2 in the Home-ventilated Neuromuscular Patient

Study Overview
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Brief Summary
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The purpose of this study is to compare the measure of the CO2 obtained on the end-tidal expiratory gas (ETCO2) with the value of CO2 obtained by transcutaneous measure (PTCO2), in home-ventilated neuromuscular patients.

Detailed Description
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Monitoring of the effectiveness of ventilation in patients with neuromuscular require to regularly measure blood gases and in particular carbon dioxide (CO2). The reference technique is arterial puncture. In recent years, a non-invasive techniques measuring CO2 by transcutaneous sensor (PTCO2) was introduced among the tools regularly used for follow-up monitoring of home ventilated patients. Another technique for monitoring CO2, originally developed for anesthesia, is based on the measurement of exhaled CO2 (ETCO2). This technique requires relatively simple equipment, and represents a potential alternative for monitoring home-ventilated patients. Recently, sensors for ETCO2 were coupled to devices for home ventilation. To the best of our knowledge, the role of ETCO2 in monitoring long-term ventilated patients has not been investigated to date. The purpose of the study is to analyze the correlation between the two non-invasive methods for measuring CO2: PTCO2 and ETCO2, in a group of home-ventilated patients with neuromuscular disease. The patients will be recruited during a routine follow-up hospitalization for their home-ventilation, and the ETCO2 will be measured during one night, in addition to the routinely measured PTCO2.

Official Title
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Validation of the Measure of ETCO2, Compared to PTCO2 and PaCO2 in the Home-ventilated Neuromuscular Patient

Conditions
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Neuromuscular Disease, Chronic Respiratory Insufficiency, Intermittent Positive-pressure Ventilation

Intervention / Treatment
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* Device: Monitoring of ETCO2 and PTCO2


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient with neuromuscular disease, treated with home invasive or non-invasive ventilation Male or female age higher or equal to 18 years Negative pregnancy test for women of childbearing age or having an effective contraception Exclusion Criteria: Acute Respiratory Failure Long-term oxygen therapy Refusal to participate in the study Plan of legal protection Pregnant Women Failure to cooperate No affiliation to a social security scheme

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Monitoring of ETCO2 and PTCO2<br>All neuromuscular patients | Device: Monitoring of ETCO2 and PTCO2<br>* Concomitant monitoring of ETCO2 and PTCO2<br>* Other names: ETCO2: Module of the BREAS Vivo 50 home ventilator;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| concordance between the nocturnal average values of ETCO2 and PTCO2 | concordance between the nocturnal average values of the CO2 measured by the two non-invasive techniques ETCO2 and PTCO2 | one night | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| concordance between the nocturnal maximal values of ETCO2 and PTCO2 | concordance between the nocturnal maximal values of the CO2 measured by the two non-invasive techniques ETCO2 and PTCO2 | one night | 
| concordance between the variation of the values of ETCO2 and PTCO2 | concordance between the variation of the values of the CO2 measured by the two non-invasive techniques ETCO2 and PTCO2 | one night | 
| concordance between the values of ETCO2, PTCO2 and arterial CO2 (PaCO2) measured at the same time | concordance between the values of ETCO2, PTCO2 and arterial CO2 (PaCO2) measured at the same time | one night | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Home ventilation, Neuromuscular disease, End tidal CO2, Transcutaneous CO2, Monitoring