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

Neuromuscular Disease Clinical Trial

— Capnovivo  

Official title:

Validation of the Measure of ETCO2, Compared to PTCO2 and PaCO2 in the Home-ventilated Neuromuscular Patient

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02068911
• Other study ID #: 2013-A01629-36
• Status: Completed
• Phase: N/A
• First received: February 20, 2014
• Last updated: February 25, 2016
• Start date: April 2014
• Est. completion date: November 2015

Study information

• Verified date: February 2016
• Source: Centre d'Investigation Clinique et Technologique 805
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Chronic Respiratory Insufficiency
• Intermittent Positive-pressure Ventilation
• Neuromuscular Disease
• Neuromuscular Diseases
• Pulmonary Valve Insufficiency
• Respiratory Insufficiency

Intervention

Device:
• Monitoring of ETCO2 and PTCO2
Concomitant monitoring of ETCO2 and PTCO2

Locations

Country	Name	City	State
France	Hopital Raymond Poincare	Garches

Sponsors (1)

Lead Sponsor	Collaborator
Centre d'Investigation Clinique et Technologique 805

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	No
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No