NCT01922401

Brief Summary

for evaluating inverse ratio ventilation of laparoscopic bariatric surgery

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 8, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 14, 2013

Completed
18 days until next milestone

Study Start

First participant enrolled

September 1, 2013

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

September 1, 2015

Status Verified

August 1, 2015

Enrollment Period

1.2 years

First QC Date

August 8, 2013

Last Update Submit

August 30, 2015

Conditions

Hypoxia

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

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

inverse ratio ventilationOTHER

change the I: E ratio 1:2-1:1-2:1

inverse ratio ventilation

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • underlying cardiopulmonary diasease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gachon University Gil Medical Center

Incheon, South Korea

Location

MeSH Terms

Conditions

Hypoxia

Condition Hierarchy (Ancestors)

Signs and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Kyung Cheon Lee, M.D

    Gachon Universiy Gil Medical Center

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

August 8, 2013

First Posted

August 14, 2013

Study Start

September 1, 2013

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

September 1, 2015

Record last verified: 2015-08

Locations

KR(1)