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

NCT ID: NCT02068911

Last Updated: 2016-02-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

28 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-04-30

Study Completion Date

2015-11-30

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.

Conditions

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Neuromuscular Disease Chronic Respiratory Insufficiency Intermittent Positive-pressure Ventilation

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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Monitoring of ETCO2 and PTCO2

All neuromuscular patients

Monitoring of ETCO2 and PTCO2

Intervention Type DEVICE

Concomitant monitoring of ETCO2 and PTCO2

Interventions

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Monitoring of ETCO2 and PTCO2

Concomitant monitoring of ETCO2 and PTCO2

Intervention Type DEVICE

Other Intervention Names

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PTCO2: Sentec Capno-Oxymetry (Sentec) ETCO2: Module of the BREAS Vivo 50 home ventilator

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre d'Investigation Clinique et Technologique 805

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Adam OGNA, MD

Role: PRINCIPAL_INVESTIGATOR

HOPITAL RAYMOND POINCARE

Locations

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Hopital Raymond Poincare

Garches, Garches, France

Site Status

Countries

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France

References

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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.

Reference Type DERIVED
PMID: 27492508 (View on PubMed)

Other Identifiers

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2013-A01629-36

Identifier Type: -

Identifier Source: org_study_id

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