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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02068911
First Posted: February 21, 2014
Last Update Posted: February 26, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Centre d'Investigation Clinique et Technologique 805
  Purpose
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.

Condition Intervention
Neuromuscular Disease Chronic Respiratory Insufficiency Intermittent Positive-pressure Ventilation Device: Monitoring of ETCO2 and PTCO2

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Validation of the Measure of ETCO2, Compared to PTCO2 and PaCO2 in the Home-ventilated Neuromuscular Patient

Further study details as provided by Centre d'Investigation Clinique et Technologique 805:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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

  • 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

  • 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 Outcome Measures:
  • 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


Enrollment: 28
Study Start Date: April 2014
Study Completion Date: November 2015
Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Monitoring of ETCO2 and PTCO2
All neuromuscular patients
Device: Monitoring of ETCO2 and PTCO2
Concomitant monitoring of ETCO2 and PTCO2
Other Names:
  • PTCO2: Sentec Capno-Oxymetry (Sentec)
  • ETCO2: Module of the BREAS Vivo 50 home ventilator

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

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   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.
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02068911


Locations
France
Hopital Raymond Poincare
Garches, France, 92380
Sponsors and Collaborators
Centre d'Investigation Clinique et Technologique 805
Investigators
Principal Investigator: Adam OGNA, MD HOPITAL RAYMOND POINCARE
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Centre d'Investigation Clinique et Technologique 805
ClinicalTrials.gov Identifier: NCT02068911     History of Changes
Other Study ID Numbers: 2013-A01629-36
First Submitted: February 20, 2014
First Posted: February 21, 2014
Last Update Posted: February 26, 2016
Last Verified: February 2016

Keywords provided by Centre d'Investigation Clinique et Technologique 805:
Neuromuscular disease
Home ventilation
End tidal CO2
Transcutaneous CO2
Monitoring

Additional relevant MeSH terms:
Respiratory Insufficiency
Pulmonary Valve Insufficiency
Neuromuscular Diseases
Respiration Disorders
Respiratory Tract Diseases
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Nervous System Diseases