Cardiopulmonary ResuscitationNCT02072343
The Effect of 10 cm Catheter Mount on Malfunction of Capnometers Under the Conditions of Water
A study testing No-DCCM, DCCM and Water 5ml in tracheal tube in people with Cardiopulmonary Resuscitation and Pulmonary Edema, run by Hanyang University at 1 site in South Korea.
Trial summary
Capnometer has been used to assess the success of intubation and the quality of cardiopulmonary resuscitation. However, capnometers can malfunction under the conditions such as pulmonary edema and hemorrhage due to the vulnerability of capnometers for water. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiopulmonary Resuscitation, Pulmonary Edema, Hemorrhage
- What is being tested?
- No-DCCM, DCCM and Water 5ml in tracheal tube
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2014to Mar 2014
- 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adults without underlying disease
Who cannot join
- Lung and heart disease
- Drinking carbonated beverages
Trial locations and contacts
1 site in 1 country.
About this study
Capnometer has been used to assess the success of intubation and the quality of cardiopulmonary resuscitation. However, capnometers can malfunction under the conditions such as pulmonary edema and hemorrhage due to the vulnerability of capnometers for water. Investigators hypothesized that the use of 10cm catheter mount will reduce the malfunction of capnometers under the conditions of water.
- Conditions
- Cardiopulmonary Resuscitation, Pulmonary Edema, Hemorrhage
- Being tested
- No-DCCM, DCCM, Water 5ml in tracheal tube, Water 10ml in tracheal tube
- Keywords
- Capnography, Catheters, Intubation
- Medical subject headings
- Pulmonary Edema, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No-DCCMDevice
Also called Proximal capnometer of DCCM, Abbreviation: DCCM, direct connect catheter mount
DCCMDevice
Also called Distal capnometer of DCCM, Abbreviation: DCCM, direct connect catheter mount
Water 5ml in tracheal tubeOther
Water 10ml in tracheal tubeOther
| Study group | Role | What they receive |
|---|---|---|
| Mainstream capnometer | Experimental | Not described Receives: Device: No-DCCM; Device: DCCM; Other: Water 5ml in tracheal tube; Other: Water 10ml in tracheal tube |
| Microstream capnograph | Experimental | Not described Receives: Device: No-DCCM; Device: DCCM; Other: Water 5ml in tracheal tube; Other: Water 10ml in tracheal tube |
What is being measured
The primary outcome is the main question the study is designed to answer.
the malfunction rate of capnograph
The malfunction of capnograph is defined that the ETCO2 level is out-of the measured range of each patient under water-free conditions. The calculation formula of malfunction rate is as follows: malfunctioning time of capnograph / total experiment time (2min).
- Water conditions in tracheal tube
- Water 5ml
- Water 10ml
- Capnometers
- Mainstream capnometer
- Microstream capnograph
- Comparison group
- No-DCCM group (proximal capnometer of DCCM)
- DCCM group (distal capnometer of DCCM)
Abbreviation : DCCM, Direct connect catheter mount
Measured: 1 day
Secondary outcomes (2)
The cumulative survival rate of capnometers under the conditions of water
- Kaplan-Meier analysis
1-1. Water conditions in tracheal tube
- Water 5ml
- Water 10ml
1-2. Capnometers
- Mainstream capnometer
- Microstream capnograph
1-3. Comparison group
- No-DCCM group (proximal capnometer of DCCM)
- DCCM group (distal capnometer of DCCM)
Abbreviation : DCCM, Direct connect catheter mount
Measured: 1 day
The consistency of ETCO2 between No-DCCM group and DCCM group under the water-free conditions
- Bland-Altman plots under water 0ml in tracheal tube. 1-1. Capnometers
- Mainstream capnometer
- Microstream capnograph 1-3. Comparison group
- No-DCCM group (proximal capnometer of DCCM)
- DCCM group (distal capnometer of DCCM)
- The intraclass correlation coefficient (ICC) under water 0ml in tracheal tube
2-1. Capnometers
- Mainstream capnometer
- Microstream capnograph
2-2. Comparison group
- No-DCCM group (proximal capnometer of DCCM)
- DCCM group (distal capnometer of DCCM)
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2014 (estimated)
- Study startMar 2014
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiopulmonary ResuscitationStudies 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
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hanyang University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wonhee Kim, Hanyang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02072343
- Sponsor's protocol ID
- Capnometry with DCCM
- Status last verified
- Mar 2014
- First submitted
- 24 Feb 2014
- Last updated
- 18 Mar 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of 10 cm Catheter Mount on Malfunction of Capnometers Under the Conditions of Water
- ClinicalTrials.gov ID
- NCT02072343
- Acronym / sponsor ID
- Capnometry with DCCM
- Conditions
- Cardiopulmonary Resuscitation, Pulmonary Edema, Hemorrhage
- Keywords
- Capnography, Catheters, Intubation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Hanyang UniversityUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 26 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.
Capnometer has been used to assess the success of intubation and the quality of cardiopulmonary resuscitation. However, capnometers can malfunction under the conditions such as pulmonary edema and hemorrhage due to the vulnerability of capnometers for water. Investigators hypothesized that the use of 10cm catheter mount will reduce the malfunction of capnometers under the conditions of water.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mainstream capnometer | Experimental | Device: No-DCCM, Device: DCCM, Other: Water 5ml in tracheal tube, Other: Water 10ml in tracheal tube |
| Microstream capnograph | Experimental | Device: No-DCCM, Device: DCCM, Other: Water 5ml in tracheal tube, Other: Water 10ml in tracheal tube |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy adults without underlying disease
Key exclusion criteria (2 listed)
- Lung and heart disease
- Drinking carbonated beverages
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 |
|---|---|---|
| No-DCCMAlso: Proximal capnometer of DCCM, Abbreviation: DCCM, direct connect catheter mount | Device | Mainstream capnometer, Microstream capnograph |
| DCCMAlso: Distal capnometer of DCCM, Abbreviation: DCCM, direct connect catheter mount | Device | Mainstream capnometer, Microstream capnograph |
| Water 5ml in tracheal tube | Other | Mainstream capnometer, Microstream capnograph |
| Water 10ml in tracheal tube | Other | Mainstream capnometer, Microstream capnograph |
Primary outcome
the malfunction rate of capnograph
Time frame: 1 day
The malfunction of capnograph is defined that the ETCO2 level is out-of the measured range of each patient under water-free conditions. The calculation formula of malfunction rate is as follows: malfunctioning time of capnograph / total experiment time (2min). 1. Water conditions in tracheal tube * Water 5ml * Water 10ml 2. Capnometers * Mainstream capnometer * Microstream capnograph 3. Comparison group * No-DCCM group (proximal capnometer of DCCM) * DCCM group (distal capnometer of DCCM) Abbreviation : DCCM, Direct connect catheter mount
2 secondary outcomes
The cumulative survival rate of capnometers under the conditions of water
Time frame: 1 day
The consistency of ETCO2 between No-DCCM group and DCCM group under the water-free conditions
Time frame: 1 day
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 18 Mar 2014.
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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 No-DCCM, DCCM and Water 5ml in tracheal tube in people with Cardiopulmonary Resuscitation and Pulmonary Edema, run by Hanyang 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 2 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 18 Mar 2014. 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?
the malfunction rate of capnograph (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Mar 2014.