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

Hemorrhage Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02072343
• Other study ID #: Capnometry with DCCM
• Status: Completed
• Phase: N/A
• First received: February 24, 2014
• Last updated: March 16, 2014
• Start date: March 2014
• Est. completion date: March 2014

Study information

• Verified date: March 2014
• Source: Hanyang University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical 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. Investigators hypothesized that the use of 10cm catheter mount will reduce the malfunction of capnometers under the conditions of water.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Healthy adults without underlying disease

Exclusion Criteria:

• Lung and heart disease

• Drinking carbonated beverages

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Cardiopulmonary Resuscitation
• Hemorrhage
• Pulmonary Edema

Intervention

Device:
• No-DCCM

• DCCM

Other:
• Water 5ml in tracheal tube

• Water 10ml in tracheal tube

Locations

Country	Name	City	State
Korea, Republic of	Hanyang University	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Hanyang University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes
Secondary	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	Yes