Back to resultsThe Effect of 10 cm Catheter Mount on Malfunction of Capnometers Under the Conditions of Water
Primary Purpose
Cardiopulmonary Resuscitation, Pulmonary Edema, Hemorrhage
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
No-DCCM
DCCM
Water 5ml in tracheal tube
Water 10ml in tracheal tube
Sponsored by
About this trial
This is an interventional basic science trial for Cardiopulmonary Resuscitation focused on measuring Capnography, Catheters, Intubation
Eligibility Criteria
Inclusion Criteria:
- Healthy adults without underlying disease
Exclusion Criteria:
- Lung and heart disease
- Drinking carbonated beverages
Sites / Locations
- Hanyang University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Mainstream capnometer
Microstream capnograph
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
The cumulative survival rate of capnometers under the conditions of water
1. 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
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)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02072343
Brief Title
The Effect of 10 cm Catheter Mount on Malfunction of Capnometers Under the Conditions of Water
Study Type
Interventional
2. Study Status
Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
March 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hanyang University
4. Oversight
5. Study Description
Brief 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. Investigators hypothesized that the use of 10cm catheter mount will reduce the malfunction of capnometers under the conditions of water.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiopulmonary Resuscitation, Pulmonary Edema, Hemorrhage
Keywords
Capnography, Catheters, Intubation
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
25 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Mainstream capnometer
Arm Type
Experimental
Arm Title
Microstream capnograph
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
No-DCCM
Other Intervention Name(s)
Proximal capnometer of DCCM, Abbreviation: DCCM, direct connect catheter mount
Intervention Type
Device
Intervention Name(s)
DCCM
Other Intervention Name(s)
Distal capnometer of DCCM, Abbreviation: DCCM, direct connect catheter mount
Intervention Type
Other
Intervention Name(s)
Water 5ml in tracheal tube
Intervention Type
Other
Intervention Name(s)
Water 10ml in tracheal tube
Primary Outcome Measure Information:
Title
the malfunction rate of capnograph
Description
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
Time Frame
1 day
Secondary Outcome Measure Information:
Title
The cumulative survival rate of capnometers under the conditions of water
Description
1. 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
Time Frame
1 day
Title
The consistency of ETCO2 between No-DCCM group and DCCM group under the water-free conditions
Description
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)
Time Frame
1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy adults without underlying disease
Exclusion Criteria:
Lung and heart disease
Drinking carbonated beverages
Facility Information:
Facility Name
Hanyang University
City
Seoul
ZIP/Postal Code
133-792
Country
Korea, Republic of
12. IPD Sharing Statement
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The Effect of 10 cm Catheter Mount on Malfunction of Capnometers Under the Conditions of Water
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