NCT02072343

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 24, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 26, 2014

Completed
3 days until next milestone

Study Start

First participant enrolled

March 1, 2014

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

March 18, 2014

Status Verified

March 1, 2014

Enrollment Period

Same day

First QC Date

February 24, 2014

Last Update Submit

March 16, 2014

Conditions

Cardiopulmonary ResuscitationPulmonary EdemaHemorrhage

Keywords

CapnographyCathetersIntubation

Outcome Measures

Primary Outcomes (1)

  • 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). 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 Outcomes (2)

  • The cumulative survival rate of capnometers under the conditions of water

    1 day

  • The consistency of ETCO2 between No-DCCM group and DCCM group under the water-free conditions

    1 day

Study Arms (2)

Mainstream capnometer

EXPERIMENTAL
Device: No-DCCMDevice: DCCMOther: Water 5ml in tracheal tubeOther: Water 10ml in tracheal tube

Microstream capnograph

EXPERIMENTAL
Device: No-DCCMDevice: DCCMOther: Water 5ml in tracheal tubeOther: Water 10ml in tracheal tube

Interventions

No-DCCMDEVICE
Also known as: Proximal capnometer of DCCM, Abbreviation: DCCM, direct connect catheter mount
Mainstream capnometerMicrostream capnograph
DCCMDEVICE
Also known as: Distal capnometer of DCCM, Abbreviation: DCCM, direct connect catheter mount
Mainstream capnometerMicrostream capnograph
Water 5ml in tracheal tubeOTHER
Mainstream capnometerMicrostream capnograph
Water 10ml in tracheal tubeOTHER
Mainstream capnometerMicrostream capnograph

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy adults without underlying disease

You may not qualify if:

  • Lung and heart disease
  • Drinking carbonated beverages

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hanyang University

Seoul, 133-792, South Korea

Location

MeSH Terms

Conditions

Pulmonary EdemaHemorrhage

Interventions

Water

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

HydroxidesAlkaliesInorganic ChemicalsAnionsIonsElectrolytesOxidesOxygen Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Emergency medicine fellow

Study Record Dates

First Submitted

February 24, 2014

First Posted

February 26, 2014

Study Start

March 1, 2014

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

March 18, 2014

Record last verified: 2014-03

Locations

KR(1)