Clinical trial NCT02068911: Concordance Between ETCO2, PTCO2 and PaCO2 in the Home-ventilated Neuromuscular Patient
Official title: Validation of the Measure of ETCO2, Compared to PTCO2 and PaCO2 in the Home-ventilated Neuromuscular Patient
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neuromuscular Disease
Chronic Respiratory Insufficiency
Intermittent Positive-pressure Ventilation
Keywords: Neuromuscular disease
Home ventilation
End tidal CO2
Transcutaneous CO2
Monitoring
Lead sponsor: Centre d'Investigation Clinique et Technologique 805
Sponsor class: OTHER
First posted: 2014-02-21
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The patients will be recruited among the neuromuscular patients treated at the University Hospital Raymond Pointcaré, Garches (France), during a routine follow-up hospitalization for their home-ventilation.

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.

Eligibility criteria: 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

Primary outcomes:
measure: concordance between the nocturnal average values of ETCO2 and PTCO2
timeFrame: one night
Secondary outcomes:
measure: concordance between the nocturnal maximal values of ETCO2 and PTCO2
timeFrame: one night
measure: concordance between the variation of the values of ETCO2 and PTCO2
timeFrame: one night
measure: concordance between the values of ETCO2, PTCO2 and arterial CO2 (PaCO2) measured at the same time
timeFrame: one night
Other outcomes:
measure: influence of circuit leakage on the gradient between PaCO2 and ETCO2
timeFrame: one night
Locations:
city: Garches
country: France
facility: Hopital Raymond Poincare
Study officials:
affiliation: HOPITAL RAYMOND POINCARE
name: Adam OGNA, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Orlikowski D, Prigent H, Ambrosi X, Vaugier I, Pottier S, Annane D, Lofaso F, Ogna A. Comparison of ventilator-integrated end-tidal CO2 and transcutaneous CO2 monitoring in home-ventilated neuromuscular patients. Respir Med. 2016 Aug;117:7-13. doi: 10.1016/j.rmed.2016.05.022. Epub 2016 May 24.