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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

Primary Purpose

Lung Cancer, Lung Lobectomy

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
I:E ratio
Sponsored by
Yonsei University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Department of Anaesthesiology and Pain Medicine, Anaesthesia and Pain Research Institute, Yonsei University College of Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

I:E ratio 1:1

Arm Description

Outcomes

Primary Outcome Measures

intrapulmonary shunt fraction
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
Mechanical Ventilator measurement : Paw, Pplat, Pmean, Compliance

Full Information

First Posted
December 18, 2011
Last Updated
December 21, 2011
Sponsor
Yonsei University
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1. Study Identification

Unique Protocol Identification Number
NCT01499212
Brief Title
Effects of Different I:E Ratio on Intrapulmonary Shunt Fraction and Oxygenation During One Lung Ventilation in the Lateral Decubitus Position
Official Title
Effects of Different Inspiratory to Expiratory Ratios on Intrapulmonary Shunt Fraction and Oxygenation During One Lung Ventilation in the Lateral Decubitus Position
Study Type
Interventional

2. Study Status

Record Verification Date
December 2011
Overall Recruitment Status
Completed
Study Start Date
July 2011 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer, Lung Lobectomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
58 (Actual)

8. Arms, Groups, and Interventions

Arm Title
I:E ratio 1:1
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
I:E ratio
Intervention Description
I:E ratio 1:1 Volume controlled ventilation TV:8ml/kg EtCO2:35-40mmHg
Primary Outcome Measure Information:
Title
intrapulmonary shunt fraction
Description
T1,T2,T3,T4 : ALL mesurement in lateral decubitus position T1-intrapulmonary shunt T2-intrapulmonary shunt T3-intrapulmonary shunt T4-intrapulmonary shunt
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)
Secondary Outcome Measure Information:
Title
Respiratory dynamic parameters
Description
Mechanical Ventilator measurement : Paw, Pplat, Pmean, Compliance
Time Frame
T1,T2,T3,T4 (same as primary outcome measure)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Young Jun Oh, MD,PhD
Organizational Affiliation
Department of Anaesthesiology and Pain Medicine, Anaesthesia and Pain Research Institute, Yonsei University College of Medicine, Seoul, Korea
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Anaesthesiology and Pain Medicine, Anaesthesia and Pain Research Institute, Yonsei University College of Medicine
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of

12. IPD Sharing Statement

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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

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