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

March 16, 2014 updated by: Wonhee Kim, Hanyang University
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy adults without underlying disease

Exclusion Criteria:

  • Lung and heart disease
  • Drinking carbonated beverages

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mainstream capnometer
Device: No-DCCM
Other Names:
  • Proximal capnometer of DCCM
  • Abbreviation: DCCM, direct connect catheter mount
Device: DCCM
Other Names:
  • Abbreviation: DCCM, direct connect catheter mount
  • Distal capnometer of DCCM
Other: Water 5ml in tracheal tube
Other: Water 10ml in tracheal tube
Experimental: Microstream capnograph
Device: No-DCCM
Other Names:
  • Proximal capnometer of DCCM
  • Abbreviation: DCCM, direct connect catheter mount
Device: DCCM
Other Names:
  • Abbreviation: DCCM, direct connect catheter mount
  • Distal capnometer of DCCM
Other: Water 5ml in tracheal tube
Other: Water 10ml in tracheal tube

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The cumulative survival rate of capnometers under the conditions of water
Time Frame: 1 day

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
Time Frame: 1 day

  1. 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)
  2. 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hanyang University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2014

Primary Completion (Actual)

March 1, 2014

Study Completion (Actual)

March 1, 2014

Study Registration Dates

First Submitted

February 24, 2014

First Submitted That Met QC Criteria

February 25, 2014

First Posted (Estimate)

February 26, 2014

Study Record Updates

Last Update Posted (Estimate)

March 18, 2014

Last Update Submitted That Met QC Criteria

March 16, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Capnometry with DCCM

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Locations

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