Hemorrhage Clinical Trial
Verified date | March 2014 |
Source | Hanyang University |
Contact | n/a |
Is FDA regulated | No |
Health authority | Korea: Institutional Review Board |
Study type | Interventional |
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.
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 |
Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Hanyang University | Seoul |
Lead Sponsor | Collaborator |
---|---|
Hanyang University |
Korea, Republic of,
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 |
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