Inverse Ratio Ventilation on Bariatric Operation | NCT01922401

Studies
Inverse Ratio Ventilation on Bariatric Operation

NCT01922401

Sponsor

Gachon University Gil Medical Center

Status

Completed

Last Update Posted

Sep 1, 2015Estimated

Enrollment

30Actual

Phase

Not Applicable

Conditions

Hypoxia

Interventions

inverse ratio ventilation

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2013

Primary Completion Date

Dec 2014Actual

Completion Date

Dec 2014Actual

First Submitted Date

Aug 8, 2013

First Submission Date that Met QC Criteria

Aug 11, 2013

First Posted Date

Aug 14, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 30, 2015

Last Update Posted Date

Sep 1, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Youn Yi Jo, Assistant professor, Gachon University Gil Medical CenterPrincipal Investigator

Lead Sponsor

Gachon University Gil Medical CenterOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
inverse ratio ventilation	Experimental	in one group change the I:E ratio during pneumoperitoneum 1:2-1:2-2:1	Other: inverse ratio ventilation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
inverse ratio ventilation	Other	change the I: E ratio 1:2-1:1-2:1	inverse ratio ventilation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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	baseline PaO2-2hour after pneumoperitoneum

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

ASA PS 1-2 obese patients(BMI>30)

Exclusion Criteria:

underlying cardiopulmonary diasease

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kyung Cheon Lee, M.D	Gachon Universiy Gil Medical Center	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Gachon University Gil Medical Center		Incheon			South Korea

Condition Browse Module

MeSH Terms

ID	Term
D000860	Hypoxia

Ancestor Terms

ID	Term
D012818	Signs and Symptoms, Respiratory
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

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Browse Branches

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