- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01499212
Effects of Different I:E Ratio on Intrapulmonary Shunt Fraction and Oxygenation During One Lung Ventilation in the Lateral Decubitus Position
December 21, 2011 updated by: Yonsei University
Effects of Different Inspiratory to Expiratory Ratios on Intrapulmonary Shunt Fraction and Oxygenation During One Lung Ventilation in the Lateral Decubitus Position
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
58
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Seoul, Korea, Republic of, 120-752
- Department of Anaesthesiology and Pain Medicine, Anaesthesia and Pain Research Institute, Yonsei University College of Medicine
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: I:E ratio 1:1
|
I:E ratio 1:1 Volume controlled ventilation TV:8ml/kg EtCO2:35-40mmHg
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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)
|
T1,T2,T3,T4 : ALL mesurement in lateral decubitus position T1-intrapulmonary shunt T2-intrapulmonary shunt T3-intrapulmonary shunt T4-intrapulmonary shunt
|
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 Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Respiratory dynamic parameters
Time Frame: T1,T2,T3,T4 (same as primary outcome measure)
|
Mechanical Ventilator measurement : Paw, Pplat, Pmean, Compliance
|
T1,T2,T3,T4 (same as primary outcome measure)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2011
Primary Completion (Actual)
November 1, 2011
Study Completion (Actual)
December 1, 2011
Study Registration Dates
First Submitted
December 18, 2011
First Submitted That Met QC Criteria
December 21, 2011
First Posted (Estimate)
December 26, 2011
Study Record Updates
Last Update Posted (Estimate)
December 26, 2011
Last Update Submitted That Met QC Criteria
December 21, 2011
Last Verified
December 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1-2011-0058
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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