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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02068911
Acronym
Capnovivo
Enrollment
28
Registered
2014-02-21
Start date
2014-04-30
Completion date
2015-11-30
Last updated
2016-02-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Neuromuscular disease, Home ventilation, End tidal CO2, Transcutaneous CO2, Monitoring

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.

Interventions

DEVICEMonitoring of ETCO2 and PTCO2

Concomitant monitoring of ETCO2 and PTCO2

Sponsors

Centre d'Investigation Clinique et Technologique 805
Lead SponsorOTHER

Study design

Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
concordance between the nocturnal average values of ETCO2 and PTCO2one nightconcordance between the nocturnal average values of the CO2 measured by the two non-invasive techniques ETCO2 and PTCO2

Secondary

MeasureTime frameDescription
concordance between the nocturnal maximal values of ETCO2 and PTCO2one nightconcordance between the nocturnal maximal values of the CO2 measured by the two non-invasive techniques ETCO2 and PTCO2
concordance between the variation of the values of ETCO2 and PTCO2one nightconcordance between the variation of the 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 timeone nightconcordance between the values of ETCO2, PTCO2 and arterial CO2 (PaCO2) measured at the same time

Other

MeasureTime frameDescription
influence of circuit leakage on the gradient between PaCO2 and ETCO2one nightevaluate the influence of circuit leakage on the gradient between PaCO2 and ETCO2

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 13, 2026