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Completed

NCT Number: NCT02068911

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hopital Raymond Poincare

Garches, 92380, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Monitoring of ETCO2 and PTCO2

Device

Concomitant monitoring of ETCO2 and PTCO2

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

Primary outcomes

  1. concordance between the nocturnal average values of ETCO2 and PTCO2

    Time frame: one night

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

Secondary outcomes

  1. concordance between the nocturnal maximal values of ETCO2 and PTCO2

    Time frame: one night

    concordance between the nocturnal maximal values of the CO2 measured by the two non-invasive techniques ETCO2 and PTCO2

  2. concordance between the variation of the values of ETCO2 and PTCO2

    Time frame: one night

    concordance between the variation of the values of the CO2 measured by the two non-invasive techniques ETCO2 and PTCO2

  3. concordance between the values of ETCO2, PTCO2 and arterial CO2 (PaCO2) measured at the same time

    Time frame: one night

    concordance between the values of ETCO2, PTCO2 and arterial CO2 (PaCO2) measured at the same time

Other outcomes

  1. influence of circuit leakage on the gradient between PaCO2 and ETCO2

    Time frame: one night

    evaluate the influence of circuit leakage on the gradient between PaCO2 and ETCO2

Sponsors and collaborators

Lead sponsor

Centre d'Investigation Clinique et Technologique 805

Other

Registry information

Official study title

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

Acronym: Capnovivo

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Feb 21, 2014
Registry last updated
Feb 26, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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