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Effects of Different I:E Ratio on Intrapulmonary Shunt Fraction and Oxygenation During One Lung Ventilation in the Lateral Decubitus Position

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Yonsei University
ClinicalTrials.gov Identifier:
NCT01499212
First received: December 18, 2011
Last updated: December 21, 2011
Last verified: December 2011
History of Changes
  Purpose

The purpose of this study is to investigate effect of increasing inspiratory time (I:E ratio 1:1) on intrapulmonary shunt fraction and oxygenation during one lung ventilation in the lateral decubitus position.


Condition Intervention
Lung Cancer
Lung Lobectomy
 Procedure: I:E ratio

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Different Inspiratory to Expiratory Ratios on Intrapulmonary Shunt Fraction and Oxygenation During One Lung Ventilation in the Lateral Decubitus Position

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Yonsei University:

Primary Outcome Measures:
  • intrapulmonary shunt fraction [ Time Frame: T1 (10min before one lung ventibation)T2 (30min after one lung ventilation started)T3 (60min after one lung ventilation started)T4 (10min after two lung ventilation) ] [ Designated as safety issue: Yes ]
    T1,T2,T3,T4 : ALL mesurement in lateral decubitus position T1-intrapulmonary shunt T2-intrapulmonary shunt T3-intrapulmonary shunt T4-intrapulmonary shunt


Secondary Outcome Measures:
  • Respiratory dynamic parameters [ Time Frame: T1,T2,T3,T4 (same as primary outcome measure) ] [ Designated as safety issue: Yes ]
    Mechanical Ventilator measurement : Paw, Pplat, Pmean, Compliance


Enrollment: 58
Study Start Date: July 2011
Study Completion Date: December 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: I:E ratio 1:1 Procedure: I:E ratio
I:E ratio 1:1 Volume controlled ventilation TV:8ml/kg EtCO2:35-40mmHg

Detailed Description:

Increasing inspiratory time(e.g. Inverse ratio ventilation) has been known that had advantage of alveolar recruitment, preventing of ateletasis. On the contrary, it has disadvantange of intrinsic PEEP, air trapping. There is few study on one lung ventilation in lateral decubitus position about this ventilation method. We were going to investigate effecf of this ventilation method.

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ASA physical status class I, II
  • Use of Double lumen tube
  • Unilateral lung lobectomy

Exclusion Criteria:

  • COPD
  • CAOD
  • Unstable hemodynamic status
  • Peak airway pressure > 30mmHg (Two lung ventilation)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01499212

Locations
Korea, Republic of
Department of Anaesthesiology and Pain Medicine, Anaesthesia and Pain Research Institute, Yonsei University College of Medicine
Seoul, Korea, Republic of, 120-752
Sponsors and Collaborators
Yonsei University
Investigators
Study Chair: Young Jun Oh, MD,PhD Department of Anaesthesiology and Pain Medicine, Anaesthesia and Pain Research Institute, Yonsei University College of Medicine, Seoul, Korea
  More Information

No publications provided

Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT01499212     History of Changes
Other Study ID Numbers: 1-2011-0058
Study First Received: December 18, 2011
Last Updated: December 21, 2011
Health Authority: South Korea:Korea food and Drug Administration

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 21, 2013