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Effects of Humidified Ventilation on Arterial Oxygenation and Respiratory Mechanics During One Lung Ventilation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Yonsei University
ClinicalTrials.gov Identifier:
NCT01636973
First received: July 5, 2012
Last updated: July 9, 2012
Last verified: July 2012
History of Changes
  Purpose

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 .


Condition Intervention
Lung Cancer
 Procedure: Vaporizing humidifier

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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer
U.S. FDA Resources

Further study details as provided by Yonsei University:

Primary Outcome Measures:
  • arterial oxygenation [ Time Frame: T1(10min before one-lung ventilation),T2(30min after one-lung ventilation),T3(60min), T4(10min after two lung ventilation) ] [ Designated as safety issue: Yes ]
    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)


Secondary Outcome Measures:
  • Respiratory dynamic parameters [ Time Frame: T1,T2,T3,T4 (same as 'primary outcome measure') ] [ Designated as safety issue: Yes ]
    T1,T2,T3,T4: T1-respiratory dynamic parameters, T2-respiratory dynamic parameters, T3-respiratory dynamic parameters, T4-respiratory dynamic parameters


Enrollment: 60
Study Start Date: March 2011
Study Completion Date: April 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vaporizing humidifier
Vaporizing humidifier applying during one-lung ventilation
 Procedure: Vaporizing humidifier
Vaporizing humidifier applying during one-lung ventilation

  Eligibility

Ages Eligible for Study:   30 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01636973

Locations
Korea, Republic of
Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine
Seoul, Korea, Republic of, 120-752
Sponsors and Collaborators
Yonsei University
Investigators
Study Chair: Young Jun Oh, M.D.,PhD. Yonsei University College of Medicine
  More Information

No publications provided

Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT01636973     History of Changes
Other Study ID Numbers: 1-2011-0027
Study First Received: July 5, 2012
Last Updated: July 9, 2012
Health Authority: Korea: Food and Drug Administration

Keywords provided by Yonsei University:
Lung cancer

Additional relevant MeSH terms:
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
 Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 16, 2013