Observational Study on the Clinical Impact of Desaturation During Liver Surgery

Completed

• Conditions: Cerebral Desaturation

• Registration Number: NCT01458262
• Lead Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)

Brief Summary

The purpose of this study is to determine the clinical impact of cerebral and systemic desaturation during liver transplantation and resection on post-operative complications.

Detailed Description

This is an observational study. Cerebral and systemic oxymetry (rSO2) using near infrared spectroscopy (NIRS, Invos 5100; Somanet- ics Corporation, Troy, MI) will be performed on all patients with 4 optodes (right and left temporal area, arm and leg). Continuous rSO2 values will be stored on a hard disk with a 15 seconds update within intraoperative period and first 4 hours after the surgery. Desaturation phases (saturation decrease more than 20% of the basal value for more than 15 seconds) will be correlated to operative procedure or events. Postoperative adverse events will be collected. A correlation between desaturation and postoperative adverse events will be done with a multiple linear regression model.

Study Timeline

• Study Start: 2011-09
• Study First Submitted: 2011-09-22
• Study First Submitted QC: 2011-10-20
• Study First Posted: 2011-10-24
• Primary Completion: 2013-10
• Status Verified: 2014-01
• Study Completion: 2014-01
• Last Update Submitted: 2014-01-27
• Last Update Posted: 2014-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• patients undergoing an hepatic resection or hepatic transplantation
• patients able to give consent with knowledge of french or english language.

Exclusion Criteria

• age< 18 years
• patients with cerebral diseases

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
define the correlation coefficient between the number of systemic and/or cerebral desaturation phases and the number of postoperative adverse events	from the beginning of anesthesia till 4 hours after the end of the surgery

Secondary Outcome Measures

Name	Time	Method
define the prevalence of systemic and cerebral desaturation phases during hepatic surgery or transplantation	from the beginning of anesthesia till 4 hours after the end of the surgery
define the correlation coefficient between systemic and/or cerebral desaturation phases and the length of stay in intensive care unit	duration of intensive care stay, an expected average of 4 days
validate the equivalence of the systemic and cerebral oxymetry	from the beginning of anesthesia till 4 hours after the end of the surgery

Trial Locations

Locations (1)

Centre hospitalier de l'Université de Montréal (CHUM); 🇨🇦 Montréal, Quebec, Canada