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

Validation of the Measure of ETCO2, Compared to 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.

Study Overview

• Status: Completed
• Conditions: Neuromuscular Disease; Chronic Respiratory Insufficiency; Intermittent Positive-pressure Ventilation
• Intervention / Treatment: Device: Monitoring of ETCO2 and PTCO2

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.

• Study Type: Observational
• Enrollment (Actual): 28

Contacts and Locations

Study Locations

• France
  • Garches, France, 92380
    • Hopital Raymond Poincare

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	one night
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	one night
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	one night

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
influence of circuit leakage on the gradient between PaCO2 and ETCO2	evaluate the influence of circuit leakage on the gradient between PaCO2 and ETCO2	one night

Collaborators and Investigators

• Sponsor: Centre d'Investigation Clinique et Technologique 805
• Investigators: Principal Investigator: Adam OGNA, MD, Hopital Raymond Poincare

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: April 1, 2014
• Primary Completion (Actual): November 1, 2015
• Study Completion (Actual): November 1, 2015

Study Registration Dates

• First Submitted: February 20, 2014
• First Submitted That Met QC Criteria: February 20, 2014
• First Posted (Estimate): February 21, 2014

Study Record Updates

• Last Update Posted (Estimate): February 26, 2016
• Last Update Submitted That Met QC Criteria: February 25, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Keywords: Monitoring; Neuromuscular disease; Home ventilation; End tidal CO2; Transcutaneous CO2
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency; Neuromuscular Diseases
• Other Study ID Numbers: 2013-A01629-36