Effects of 1:1 Inspiratory to Expiratory Ratios on Oxygenation and Intrapulmonary Shunt Fraction During One Lung Ventilation in the Obese Patients

March 14, 2019 updated by: Yonsei University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

36

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

  • Korea, Republic of
      • 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:

  1. Above 40 years of age.
  2. American Society of Anesthesiologists (ASA) Physical Status I, II, III.
  3. Obesity (BMI >25 kg/ m2 )
  4. thoracic surgical procedure

Exclusion Criteria:

  1. severe functional liver or kidney disease
  2. diagnosed HF ( NYHA class >3)
  3. reduced pulmonary diffusion capacity < 80%

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: OTHER
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: I:E ratio 1:2
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.
Procedure: I:E ratio 1:2
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.
Active Comparator: I:E ratio 1:1
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.
Procedure: I:E ratio 1:1
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes of the intrapulmonary shunt fraction and respiratory dynamic parameter
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)
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
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

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, 2014

Primary Completion (Actual)

January 1, 2015

Study Completion (Actual)

January 1, 2015

Study Registration Dates

First Submitted

July 3, 2014

First Submitted That Met QC Criteria

July 3, 2014

First Posted (Estimate)

July 9, 2014

Study Record Updates

Last Update Posted (Actual)

March 18, 2019

Last Update Submitted That Met QC Criteria

March 14, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4-2014-0302

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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