End Tidal Carbon Dioxide of Patients Undergoing General AnesthesiaNCT02184728
Comparison of End-tidal Carbon Dioxide (ETCO2) Measured by Transportable Capnometer (EMMATM) and the Arterial pCO2 in General Anesthesia
A study testing End-tidal CO2(portable capnometer) in people with End Tidal Carbon Dioxide of Patients Undergoing General Anesthesia, run by Inje University at 1 site in South Korea.
Trial summary
An end-tidal CO 2 monitor (capnometer) is used most often as a noninvasive substitute for PaCO2 in anesthesia, anesthetic recovery and intensive care. There is now also wide-spread use of capnometry on-site at emergency and trauma fields. So, portable device can be used usefully. Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- End Tidal Carbon Dioxide of Patients Undergoing General Anesthesia
- What is being tested?
- End-tidal CO2(portable capnometer)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2014to Mar 2015
- Phase
- Interventional
- 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 20 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients who anticipated arterial gas analyze intraoperatively
Who cannot join
- patients who didn't get arterial line
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Inje University Seoul Paik Hospital, Seoul, Korea
Seoul, Jung-Gu,, 100-032
About this study
An end-tidal CO 2 monitor (capnometer) is used most often as a noninvasive substitute for PaCO2 in anesthesia, anesthetic recovery and intensive care. There is now also wide-spread use of capnometry on-site at emergency and trauma fields. So, portable device can be used usefully.
- Being tested
- End-tidal CO2(portable capnometer)
- Keywords
- end-tidal CO2, capnometer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
End-tidal CO2(portable capnometer)Device
Also called EMMA(TM )
End-tidal CO2(portable capnometer: EMMATM, Side stream capnometry module:Datex-Ohmeda S5 Anesthesia Monitor )levels were recorded at the time of arterial blood gas sampling.
| Study group | Role | What they receive |
|---|---|---|
| EMMA(TM) | No intervention | A small capnograph for measuring ET-CO2 - the EMMA capnometer
1 Receives: Device: End-tidal CO2(portable capnometer) |
What is being measured
The primary outcome is the main question the study is designed to answer.
End-tidal CO2
End-tidal CO2(portable capnometer: EMMATM, Side stream capnometry module:Datex-Ohmeda S5 Anesthesia Monitor )levels were recorded at the time of arterial blood gas sampling.
Measured: During operation (2-4 times)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2014 (estimated)
- Study startJun 2014
- Primary completionJan 2015
- Study completionMar 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 End Tidal Carbon Dioxide of Patients Undergoing General AnesthesiaStudies 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
- Interventional
- Phase
- Phase N/A
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inje University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sira Bang, Inje University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02184728
- Sponsor's protocol ID
- IIT-2014-215
- Status last verified
- Mar 2015
- First submitted
- 3 Jul 2014
- Last updated
- 25 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Kim KW, Choi HR, Bang SR, Lee JW. Comparison of end-tidal CO2 measured by transportable capnometer (EMMA capnograph) and arterial pCO2 in general anesthesia. J Clin Monit Comput. 2016 Oct;30(5):737-41. doi: 10.1007/s10877-015-9748-x. Epub 2015 Aug 12.
PubMed 26264607
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of End-tidal Carbon Dioxide (ETCO2) Measured by Transportable Capnometer (EMMATM) and the Arterial pCO2 in General Anesthesia
- ClinicalTrials.gov ID
- NCT02184728
- Acronym / sponsor ID
- IIT-2014-215
- Keywords
- end-tidal CO2, capnometer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Inje UniversityUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Jan 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 9 Jul 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.
An end-tidal CO 2 monitor (capnometer) is used most often as a noninvasive substitute for PaCO2 in anesthesia, anesthetic recovery and intensive care. There is now also wide-spread use of capnometry on-site at emergency and trauma fields. So, portable device can be used usefully.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EMMA(TM) | No intervention | Device: End-tidal CO2(portable capnometer)A small capnograph for measuring ET-CO2 - the EMMA capnometer 1 |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients who anticipated arterial gas analyze intraoperatively
Key exclusion criteria (1 listed)
- patients who didn't get arterial line
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 |
|---|---|---|
| End-tidal CO2(portable capnometer)Also: EMMA(TM )End-tidal CO2(portable capnometer: EMMATM, Side stream capnometry module:Datex-Ohmeda S5 Anesthesia Monitor )levels were recorded at the time of arterial blood gas sampling. | Device | EMMA(TM) |
Primary outcome
End-tidal CO2
Time frame: During operation (2-4 times)
End-tidal CO2(portable capnometer: EMMATM, Side stream capnometry module:Datex-Ohmeda S5 Anesthesia Monitor )levels were recorded at the time of arterial blood gas sampling.
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 25 Mar 2015.
- Derived from this study: PubMed 26264607Kim KW, Choi HR, Bang SR, Lee JW. Comparison of end-tidal CO2 measured by transportable capnometer (EMMA capnograph) and arterial pCO2 in general anesthesia. J Clin Monit Comput. 2016 Oct;30(5):737-41. doi: 10.1007/s10877-015-9748-x. Epub 2015 Aug 12.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing End-tidal CO2(portable capnometer) in people with End Tidal Carbon Dioxide of Patients Undergoing General Anesthesia, run by Inje University at 1 site in South Korea.
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 1 inclusion and 1 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 25 Mar 2015. 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 South Korea. 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?
End-tidal CO2 (time frame: During operation (2-4 times)). 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 NCT02184728, 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 25 Mar 2015.