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CompletedNCT02068911CapnovivoUpdated Feb 26, 2016

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

An observational study in Neuromuscular Disease, Chronic Respiratory Insufficiency and Intermittent Positive-pressure Ventilation, sponsored by Centre d'Investigation Clinique et Technologique 805. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-02-26.

Sponsored by Centre d'Investigation Clinique et Technologique 805 · Observational

Study type
Observational
Time perspective
Prospective
Enrollment
28
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

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Conditions studied

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

Keywords

  • Neuromuscular disease
  • Home ventilation
  • End tidal CO2
  • Transcutaneous CO2
  • Monitoring
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In context

Respiratory Insufficiency

1,650 studies on the registry are indexed under Respiratory Insufficiency; 296 are open to participants now.

This study's enrollment of 28 is below the median of 100 across 545 observational studies indexed under Respiratory Insufficiency.

Browse Respiratory Insufficiency studies →

Lead sponsor

Centre d'Investigation Clinique et Technologique 805 is the lead sponsor of 74 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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.

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

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
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Study design

Time perspective
Prospective
Enrollment
28 participants (actual)
Patient registry
No

Groups and cohorts

  • Monitoring of ETCO2 and PTCO2

    All neuromuscular patients

    Device: Monitoring of ETCO2 and PTCO2

Interventions

  • DeviceMonitoring of ETCO2 and PTCO2

    Concomitant monitoring of ETCO2 and PTCO2

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

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What researchers measure

Primary outcomes

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

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

    Time frame: one night

Secondary outcomes

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

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

    Time frame: one night

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

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

    Time frame: one night

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

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

    Time frame: one night

Other outcomes

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

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

    Time frame: one night

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Study locations

1 site
  • Hopital Raymond Poincare
    Garches, 92380, France
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References and documents

Publications

  • 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. PubMed 27492508 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 26, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02068911
Lead sponsor
Centre d'Investigation Clinique et Technologique 805
Responsible party
Sponsor
First posted
Feb 21, 2014
Start date
Apr 2014
Primary completion
Nov 2015
Completion
Nov 2015
Last update
Feb 26, 2016

Study contacts

Adam OGNA, MD
principal investigator · HOPITAL RAYMOND POINCARE

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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