The Effect of 10 cm Catheter Mount on Malfunction of Capnometers Under the Conditions of Water

Study Overview
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Brief Summary
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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
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Cardiopulmonary Resuscitation, Pulmonary Edema, Hemorrhage

Intervention / Treatment
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* Device: No-DCCM
* Device: DCCM
* Other: Water 5ml in tracheal tube
* Other: Water 10ml in tracheal tube


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy adults without underlying disease Exclusion Criteria: Lung and heart disease Drinking carbonated beverages

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mainstream capnometer<br> | Device: No-DCCM<br> <br> * Other names: Abbreviation: DCCM, direct connect catheter mount;Device: DCCM<br> <br> * Other names: Abbreviation: DCCM, direct connect catheter mount;Other: Water 5ml in tracheal tube<br> <br> Other: Water 10ml in tracheal tube<br> <br> |
| Experimental: Microstream capnograph<br> | Device: No-DCCM<br> <br> * Other names: Abbreviation: DCCM, direct connect catheter mount;Device: DCCM<br> <br> * Other names: Abbreviation: DCCM, direct connect catheter mount;Other: Water 5ml in tracheal tube<br> <br> Other: Water 10ml in tracheal tube<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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) | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Capnography, Catheters, Intubation