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

NCT02068911 | Completed

• 1 other identifier: 2013-A01629-36
• Study Type: observational
• Target: 28
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

Neuromuscular disease; Home ventilation; End tidal CO2; Transcutaneous CO2; Monitoring

Outcome Measures

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

  one night

Secondary Outcomes (3)

• concordance between the nocturnal maximal values of ETCO2 and PTCO2

  one night

• concordance between the variation of the values of ETCO2 and PTCO2

  one night

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

  one night

Other Outcomes (1)

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

  one night

Study Arms (1)

Monitoring of ETCO2 and PTCO2

All neuromuscular patients

Device: Monitoring of ETCO2 and PTCO2

Interventions

Monitoring of ETCO2 and PTCO2 DEVICE

Concomitant monitoring of ETCO2 and PTCO2

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

Monitoring of ETCO2 and PTCO2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre d'Investigation Clinique et Technologique 805: lead

Study Sites (1)

Hopital Raymond Poincare

Garches, Garches, 92380, France

Location

Related Publications (1)

• 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.

  PMID: 27492508 DERIVED

MeSH Terms

Conditions

Neuromuscular Diseases

Interventions

Blood Gas Monitoring, Transcutaneous

Condition Hierarchy (Ancestors)

Nervous System Diseases

Intervention Hierarchy (Ancestors)

Oximetry; Blood Gas Analysis; Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Heart Function Tests; Diagnostic Techniques, Cardiovascular; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Investigative Techniques

Study Officials

• Adam OGNA, MD

  HOPITAL RAYMOND POINCARE

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2014
• First Posted: February 21, 2014
• Study Start: April 1, 2014
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: February 26, 2016

Record last verified: 2016-02

Locations

FR (1)