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

Colorectal Neoplasms Clinical Trial

Official title:

Effect of Inverse Ratioventilation on Laparoscopic Low Anterior Resection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01897584
• Other study ID #: GBIRB2013-127
• Secondary ID: GBIRB2013-127
• Status: Completed
• Phase: N/A
• First received: June 26, 2013
• Last updated: August 30, 2015
• Start date: July 2013
• Est. completion date: December 2014

Study information

• Verified date: August 2015
• Source: Gachon University Gil Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 70 Years

Eligibility

Inclusion Criteria:

• colorectal cancer

Exclusion Criteria:

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Colorectal Neoplasms

Intervention

Other:
• inverse IE
in only one group changes of I:E ratio would be applied

Locations

Country	Name	City	State
Korea, Republic of	Kyung Cheon Lee	Incheon

Sponsors (1)

Lead Sponsor	Collaborator
Gachon University Gil Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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.	immediately before pneumoperitoneum in the Trendelenburg position, every 5 min up to 20 after I:E ratio 1:1	Yes