NCT01897584

Brief Summary

Changes of inspiration: expiration ration from 1:2 to 1:1 could improve the arterial oxygenation and respiratory mechanics

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 Jul 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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 26, 2013

Completed
5 days until next milestone

Study Start

First participant enrolled

July 1, 2013

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 12, 2013

Completed
1.4 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

1.4 years

First QC Date

June 26, 2013

Last Update Submit

August 30, 2015

Conditions

Colorectal Neoplasms

Keywords

laparoscopy, Trendelenburg Position, ventilation

Outcome Measures

Primary Outcomes (1)

  • arterial oxygenation (PaO2)

    sampling for arterial blood from arterial cannular will be analyzed 10 min after anesthetic induction, 20 min after pneumoperitoneum, 40 min after pneumoperitoneum and operation end.

    baseline PaO2- 2 hour after pneumoperitoneum

Secondary Outcomes (1)

  • cerebral perfusion pressure

    immediately before pneumoperitoneum in the Trendelenburg position, every 5 min up to 20 after I:E ratio 1:1

Study Arms (1)

Inverse IE

EXPERIMENTAL

in only one group, inspiration to expiration ratio 1:2 to 1:1 will be applied during pneumoperitoneum

Other: inverse IE

Interventions

inverse IEOTHER

in only one group changes of I:E ratio would be applied

Also known as: inverse I:E
Inverse IE

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • colorectal cancer

You may not qualify if:

  • obesity (BMI\>35), uncontrolled hypertension, coronary artery disease, uncompensated cardiovascular disease, current respiratory disease, open procedure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kyung Cheon Lee

Incheon, South Korea

Location

MeSH Terms

Conditions

Colorectal NeoplasmsRespiratory Aspiration

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesRespiration DisordersRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Hyun Jeong Kwak, M.D., Ph.D

    Gachon University Gil Medical Center

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

June 26, 2013

First Posted

July 12, 2013

Study Start

July 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)