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Inverse Ratio Ventilation on Bariatric Operation

Primary Purpose

Hypoxia

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
inverse ratio ventilation
Sponsored by
Gachon University Gil Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hypoxia

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • ASA PS 1-2 obese patients(BMI>30)

Exclusion Criteria:

  • underlying cardiopulmonary diasease

Sites / Locations

  • Gachon University Gil Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

inverse ratio ventilation

Arm Description

in one group change the I:E ratio during pneumoperitoneum 1:2-1:2-2:1

Outcomes

Primary Outcome Measures

Arterial oxygenation (PaO2)
sampling for arterial blood from arterial cannular weill be analysed 10 min after anesthetic induction, 20 min after pneurmoperitoneum (PP)with 1:2 of IE ratio, 20 min after after pneurmoperitoneum (PP)with 1:1 of IE ratio, after pneurmoperitoneum (PP)with 2:1 of IE ratio and end of operation

Secondary Outcome Measures

Full Information

First Posted
August 8, 2013
Last Updated
August 30, 2015
Sponsor
Gachon University Gil Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01922401
Brief Title
Inverse Ratio Ventilation on Bariatric Operation
Official Title
Effects of a Changes in Inspiratory to Expiratory Ratio on Respiratory Mechanics and Oxygenation During Laparosopic Bariatric Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
September 2013 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gachon University Gil Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
for evaluating inverse ratio ventilation of laparoscopic bariatric surgery
Detailed Description
inverse ratio ventilation had been improve the oxygenation and respiratory mechanics during care of ARDS patients or during general anesthesia. We hypothized inverse ratio ventilatio could improve the oxygenation and respiratory mechanics on the obese patient also.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypoxia

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
inverse ratio ventilation
Arm Type
Experimental
Arm Description
in one group change the I:E ratio during pneumoperitoneum 1:2-1:2-2:1
Intervention Type
Other
Intervention Name(s)
inverse ratio ventilation
Intervention Description
change the I: E ratio 1:2-1:1-2:1
Primary Outcome Measure Information:
Title
Arterial oxygenation (PaO2)
Description
sampling for arterial blood from arterial cannular weill be analysed 10 min after anesthetic induction, 20 min after pneurmoperitoneum (PP)with 1:2 of IE ratio, 20 min after after pneurmoperitoneum (PP)with 1:1 of IE ratio, after pneurmoperitoneum (PP)with 2:1 of IE ratio and end of operation
Time Frame
baseline PaO2-2hour after pneumoperitoneum

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ASA PS 1-2 obese patients(BMI>30) Exclusion Criteria: underlying cardiopulmonary diasease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kyung Cheon Lee, M.D
Organizational Affiliation
Gachon Universiy Gil Medical Center
Official's Role
Study Director
Facility Information:
Facility Name
Gachon University Gil Medical Center
City
Incheon
Country
Korea, Republic of

12. IPD Sharing Statement

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Inverse Ratio Ventilation on Bariatric Operation

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