Back to resultsEffects of 1:1 Inspiratory to Expiratory Ratios on Oxygenation and Intrapulmonary Shunt Fraction During One Lung Ventilation in the Obese Patients
Primary Purpose
Obese Patients, One Lung Ventilation
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
I:E ratio 1:2
I:E ratio 1:1
Sponsored by
About this trial
This is an interventional other trial for Obese Patients, One Lung Ventilation
Eligibility Criteria
Inclusion Criteria:
- Above 40 years of age.
- American Society of Anesthesiologists (ASA) Physical Status I, II, III.
- Obesity (BMI >25 kg/ m2 )
- thoracic surgical procedure
Exclusion Criteria:
- severe functional liver or kidney disease
- diagnosed HF ( NYHA class >3)
- reduced pulmonary diffusion capacity < 80%
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 2
Arm Type
Active Comparator
Active Comparator
Arm Label
I:E ratio 1:2
I:E ratio 1:1
Arm Description
We plan to evaluate the improvement on respiratory function with different ventilation I:E ratios (1:2 vs. 1:1) during the one-lung ventilation in an obese patients.
The purpose of our study is to compare the effects of minimal prolonged 1:1 IE ratioventilation on respiratory mechanics and oxygenation with conventional 1:2 IE ratio ventilation during OLV in obese patients.
Outcomes
Primary Outcome Measures
Changes of the intrapulmonary shunt fraction and respiratory dynamic parameter
shunt fraction Qs/Qt = (CcO2- CaO2)/(CcO2- CvO2), CcO2 = Hgb x 1.34 x ScO2 + PcO2 x 0.003, lung compliance : Compliance= Vt / Pplat, physiologic dead space : Vd/Vt = 1.14 x (PaCO2 - PETCO2)/PaCO2- 0.005
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02185378
Brief Title
Effects of 1:1 Inspiratory to Expiratory Ratios on Oxygenation and Intrapulmonary Shunt Fraction During One Lung Ventilation in the Obese Patients
Official Title
Effects of 1:1 Inspiratory to Expiratory Ratios on Oxygenation and Intrapulmonary Shunt Fraction During One Lung Ventilation in the Obese Patients
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
July 2014 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
January 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
One-lung ventilation, even in patients with healthy weight, causes an impairment in gas-exchange and respiratory mechanics. We hypothesized that oxygenation during the one-lung ventilation in obese patients would be improved by applying inverse-ratio ventilation, reducing atelectasis in the dependent lung and resulting in reduced shunt. Because of the restrictive ventilatory effects of obesity, these patients often show a decreased functional residual capacity and decreased expiratory reserve volume, leading to an overall decreased tidal volume. These reduction leads to arterial hypoxemia, V-Q mismatch and Rt to Lt shunting. There are few studies on the one lung ventilation in obese patients about this prolonged inspiratory time ventilatory method. We plan to investigate the effect of this ventilation method in obese patients during one lung ventilation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obese Patients, One Lung Ventilation
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Non-Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
I:E ratio 1:2
Arm Type
Active Comparator
Arm Description
We plan to evaluate the improvement on respiratory function with different ventilation I:E ratios (1:2 vs. 1:1) during the one-lung ventilation in an obese patients.
Arm Title
I:E ratio 1:1
Arm Type
Active Comparator
Arm Description
The purpose of our study is to compare the effects of minimal prolonged 1:1 IE ratioventilation on respiratory mechanics and oxygenation with conventional 1:2 IE ratio ventilation during OLV in obese patients.
Intervention Type
Procedure
Intervention Name(s)
I:E ratio 1:2
Intervention Description
We plan to evaluate the improvement on respiratory function with different ventilation I:E ratios (1:2 vs. 1:1) during the one-lung ventilation in an obese patients.
Intervention Type
Procedure
Intervention Name(s)
I:E ratio 1:1
Intervention Description
The purpose of our study is to compare the effects of minimal prolonged 1:1 IE ratioventilation on respiratory mechanics and oxygenation with conventional 1:2 IE ratio ventilation during OLV in obese patients.
Primary Outcome Measure Information:
Title
Changes of the intrapulmonary shunt fraction and respiratory dynamic parameter
Description
shunt fraction Qs/Qt = (CcO2- CaO2)/(CcO2- CvO2), CcO2 = Hgb x 1.34 x ScO2 + PcO2 x 0.003, lung compliance : Compliance= Vt / Pplat, physiologic dead space : Vd/Vt = 1.14 x (PaCO2 - PETCO2)/PaCO2- 0.005
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)
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:
Above 40 years of age.
American Society of Anesthesiologists (ASA) Physical Status I, II, III.
Obesity (BMI >25 kg/ m2 )
thoracic surgical procedure
Exclusion Criteria:
severe functional liver or kidney disease
diagnosed HF ( NYHA class >3)
reduced pulmonary diffusion capacity < 80%
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
Official's Role
Principal Investigator
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
Learn more about this trial
Effects of 1:1 Inspiratory to Expiratory Ratios on Oxygenation and Intrapulmonary Shunt Fraction During One Lung Ventilation in the Obese Patients
We'll reach out to this number within 24 hrs