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Effect Inverse Ratio Ventilation on Arterial Oxygenation and Respiratory Mechanics During lapaLAR

Primary Purpose

Colorectal Neoplasms

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

About this trial

This is an interventional prevention trial for Colorectal Neoplasms focused on measuring laparoscopy, Trendelenburg Position, ventilation

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • colorectal cancer

Exclusion Criteria:

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

Sites / Locations

  • Kyung Cheon Lee

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Inverse IE

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

cerebral perfusion pressure
cerebral perfusion pressure would calculate as mean arterial pressure-central venous pressure from immediately before pneumoperitoneum in the Trendelenburg position, every 5 min up to 20 after I:E ratio 1:1.

Full Information

First Posted
June 26, 2013
Last Updated
August 30, 2015
Sponsor
Gachon University Gil Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01897584
Brief Title
Effect Inverse Ratio Ventilation on Arterial Oxygenation and Respiratory Mechanics During lapaLAR
Official Title
Effect of Inverse Ratioventilation on Laparoscopic Low Anterior Resection
Study Type
Interventional

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
July 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
Changes of inspiration: expiration ration from 1:2 to 1:1 could improve the arterial oxygenation and respiratory mechanics
Detailed Description
Inverse ratio ventilation already known as effective to improve the oxygenation and respiratory mechanics in the ARDS patients. Recently, there were report of decrease in airway pressure and improve in respiratory compliance during inverse ration ventilation undergoing one lung ventilation. We hypothesized that changes of inspiration and expiration ratio from 1:2 to 1:1 could improve the arterial oxygenation and respiratory mechanics in the patients who undergoing laparoscopic low anterior resection. However, prolonged inspiratory time might compromise cerebral perfusion pressure due to an elevation in central venous pressure and concomitant reductions in mean arterial pressure.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Neoplasms
Keywords
laparoscopy, Trendelenburg Position, ventilation

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Inverse IE
Arm Type
Experimental
Arm Description
in only one group, inspiration to expiration ratio 1:2 to 1:1 will be applied during pneumoperitoneum
Intervention Type
Other
Intervention Name(s)
inverse IE
Other Intervention Name(s)
inverse I:E
Intervention Description
in only one group changes of I:E ratio would be applied
Primary Outcome Measure Information:
Title
arterial oxygenation (PaO2)
Description
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.
Time Frame
baseline PaO2- 2 hour after pneumoperitoneum
Secondary Outcome Measure Information:
Title
cerebral perfusion pressure
Description
cerebral perfusion pressure would calculate as mean arterial pressure-central venous pressure from immediately before pneumoperitoneum in the Trendelenburg position, every 5 min up to 20 after I:E ratio 1:1.
Time Frame
immediately before pneumoperitoneum in the Trendelenburg position, every 5 min up to 20 after I:E ratio 1:1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: colorectal cancer Exclusion Criteria: obesity (BMI>35), uncontrolled hypertension, coronary artery disease, uncompensated cardiovascular disease, current respiratory disease, open procedure
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hyun Jeong Kwak, M.D., Ph.D
Organizational Affiliation
Gachon University Gil Medical Center
Official's Role
Study Director
Facility Information:
Facility Name
Kyung Cheon Lee
City
Incheon
Country
Korea, Republic of

12. IPD Sharing Statement

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Effect Inverse Ratio Ventilation on Arterial Oxygenation and Respiratory Mechanics During lapaLAR

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