Neuromuscular DiseaseCapnovivoNCT02068911
Concordance Between ETCO2, PTCO2 and PaCO2 in the Home-ventilated Neuromuscular Patient
An observational study of Neuromuscular Disease and Chronic Respiratory Insufficiency, run by Centre d'Investigation Clinique et Technologique 805 at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuromuscular Disease, Chronic Respiratory Insufficiency, Intermittent Positive-pressure Ventilation
- What is being tested?
- Monitoring of ETCO2 and PTCO2
- Type of treatment
- Medical device
- How many people
- 28 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2014to Nov 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Neuromuscular Disease, Chronic Respiratory Insufficiency, Intermittent Positive-pressure Ventilation
- Being tested
- Monitoring of ETCO2 and PTCO2
- Keywords
- Neuromuscular disease, Home ventilation, End tidal CO2, Transcutaneous CO2, Monitoring
- Medical subject headings
- Neuromuscular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Monitoring of ETCO2 and PTCO2Device
Also called PTCO2: Sentec Capno-Oxymetry (Sentec), ETCO2: Module of the BREAS Vivo 50 home ventilator
Concomitant monitoring of ETCO2 and PTCO2
| Study group | Role | What they receive |
|---|---|---|
| Monitoring of ETCO2 and PTCO2 | All neuromuscular patients Receives: Device: Monitoring of ETCO2 and PTCO2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: one night
Secondary outcomes (3)
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
Measured: 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
Measured: 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
Measured: one night
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2014 (estimated)
- Study startApr 2014
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neuromuscular DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre d'Investigation Clinique et Technologique 805
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Adam OGNA, MD, Principal investigator, HOPITAL RAYMOND POINCARE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02068911
- Sponsor's protocol ID
- 2013-A01629-36
- Acronym
- Capnovivo
- Status last verified
- Feb 2016
- First submitted
- 20 Feb 2014
- Last updated
- 26 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 27492508
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of the Measure of ETCO2, Compared to PTCO2 and PaCO2 in the Home-ventilated Neuromuscular Patient
- ClinicalTrials.gov ID
- NCT02068911
- Acronym / sponsor ID
- Capnovivo / 2013-A01629-36
- Conditions
- Neuromuscular Disease, Chronic Respiratory Insufficiency, Intermittent Positive-pressure Ventilation
- Keywords
- Neuromuscular disease, Home ventilation, End tidal CO2, Transcutaneous CO2, Monitoring
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Centre d'Investigation Clinique et Technologique 805University, hospital or other
- Study start
- Apr 2014
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 21 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Monitoring of ETCO2 and PTCO2 | – | Device: Monitoring of ETCO2 and PTCO2All neuromuscular patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- Acute Respiratory Failure
- Long-term oxygen therapy
- Refusal to participate in the study
- Plan of legal protection
- Pregnant Women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Monitoring of ETCO2 and PTCO2Also: PTCO2: Sentec Capno-Oxymetry (Sentec), ETCO2: Module of the BREAS Vivo 50 home ventilatorConcomitant monitoring of ETCO2 and PTCO2 | Device | Monitoring of ETCO2 and PTCO2 |
Primary outcome
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
3 secondary outcomes
concordance between the nocturnal maximal values of ETCO2 and PTCO2
Time frame: one night
concordance between the variation of the values of ETCO2 and PTCO2
Time frame: one night
concordance between the values of ETCO2, PTCO2 and arterial CO2 (PaCO2) measured at the same time
Time frame: one night
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2016.
- Derived from this study: PubMed 27492508Orlikowski 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adam OGNA, MD principal investigator
HOPITAL RAYMOND POINCARE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neuromuscular Disease and Chronic Respiratory Insufficiency, run by Centre d'Investigation Clinique et Technologique 805 at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
concordance between the nocturnal average values of ETCO2 and PTCO2 (time frame: one night). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02068911, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2016.