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

Completed

• Conditions: Chronic Respiratory Insufficiency; Intermittent Positive-pressure Ventilation; Neuromuscular Disease
• Interventions: Device: Monitoring of ETCO2 and PTCO2

• Registration Number: NCT02068911
• Lead Sponsor: Centre d'Investigation Clinique et Technologique 805

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2014-02-20
• Study First Submitted QC: 2014-02-20
• Study First Posted: 2014-02-21
• Study Start: 2014-04
• Primary Completion: 2015-11
• Study Completion: 2015-11
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-25
• Last Update Posted: 2016-02-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Monitoring of ETCO2 and PTCO2	Monitoring of ETCO2 and PTCO2	All neuromuscular patients

Primary Outcome Measures

Name	Time	Method
concordance between the nocturnal average values of ETCO2 and PTCO2	one night	concordance between the nocturnal average values of the CO2 measured by the two non-invasive techniques ETCO2 and PTCO2

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hopital Raymond Poincare; 🇫🇷 Garches, France