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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified February 2014 by Centre d'Investigation Clinique et Technologique 805
Sponsor:
Information provided by (Responsible Party):
Centre d'Investigation Clinique et Technologique 805
ClinicalTrials.gov Identifier:
NCT02068911
First received: February 20, 2014
Last updated: NA
Last verified: February 2014
History: No changes posted
  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

Resource links provided by NLM:


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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    evaluate the influence of circuit leakage on the gradient between PaCO2 and ETCO2


Estimated Enrollment: 30
Study Start Date: March 2014
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02068911

Contacts
Contact: Adam OGNA, MD 33(1)47107778 adam.ogna@rpc.aphp.fr
Contact: David ORLIKOWSKI, MDPHD 33(1)47107776 david.orlikowski@rpc.aphp.fr

Locations
France
Hopital Raymond Poincare Not yet recruiting
Garches, France, 92380
Contact: Adam OGNA, MD    33(1)47107778    adam.ogna@rpc.aphp.fr   
Contact: Sandra POTTIER, CRA    33(1)47104469    sandra.pottier@rpc.aphp.fr   
Principal Investigator: Adam OGNA, MD         
Sub-Investigator: David ORLIKOWSKI, MDPHD         
Sub-Investigator: Helene PRIGENT, MD         
Sponsors and Collaborators
Centre d'Investigation Clinique et Technologique 805
Investigators
Principal Investigator: Adam OGNA, MD HOPITAL RAYMOND POINCARE
  More Information

No publications provided

Responsible Party: Centre d'Investigation Clinique et Technologique 805
ClinicalTrials.gov Identifier: NCT02068911     History of Changes
Other Study ID Numbers: 2013-A01629-36
Study First Received: February 20, 2014
Last Updated: February 20, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

Additional relevant MeSH terms:
Neuromuscular Diseases
Respiratory Insufficiency
Nervous System Diseases
Respiration Disorders
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on August 21, 2014