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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01636973
Other study ID # 1-2011-0027
Secondary ID
Status Completed
Phase N/A
First received July 5, 2012
Last updated July 9, 2012
Start date March 2011
Est. completion date April 2012

Study information

Verified date July 2012
Source Yonsei University
Contact n/a
Is FDA regulated No
Health authority Korea: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

A continuous loss of moisture and heat occurs during mechanical ventilation and prediposes patients to airway damage. Vaporizing humidifier has known to be advantages of improvement of oxygenation and protection of airway damage. However, there is a lack of study about the effect of humidified ventilation on oxygenation and respiratory mechanics during one-lung ventilation. We therefore invesgate that the effect of humidified ventilation on oxygenation and respiratory mechanics during one-lung ventilation .


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date April 2012
Est. primary completion date January 2012
Accepts healthy volunteers No
Gender Both
Age group 30 Years to 75 Years
Eligibility Inclusion Criteria:

- ASA physical status class I,II

- Unilateral lung lobectomy

- Use of one-lung ventilation

Exclusion Criteria:

- COPD

- CAOD

- Unstable cardiovascular status

- Peak inspiratory pressure > 30 mmHg

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Outcomes Assessor)


Related Conditions & MeSH terms


Intervention

Procedure:
Vaporizing humidifier
Vaporizing humidifier applying during one-lung ventilation

Locations

Country Name City State
Korea, Republic of Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine Seoul

Sponsors (1)

Lead Sponsor Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary arterial oxygenation T1,T2,T3,T4: all measurement in lateral position, T1-arterial oxygenation(PaO2), T2-arterial oxygenation(PaO2),T3-arterial oxygenation(PaO2),T4-arterial oxygenation(PaO2) T1(10min before one-lung ventilation),T2(30min after one-lung ventilation),T3(60min), T4(10min after two lung ventilation) Yes
Secondary Respiratory dynamic parameters T1,T2,T3,T4: T1-respiratory dynamic parameters, T2-respiratory dynamic parameters, T3-respiratory dynamic parameters, T4-respiratory dynamic parameters T1,T2,T3,T4 (same as 'primary outcome measure') Yes
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