Observational Study on the Clinical Impact of Desaturation During Liver Surgery

January 27, 2014 updated by: Centre hospitalier de l'Université de Montréal (CHUM)

Observational Study on the Clinical Impact of Systemic and Cerebral Desaturation During Liver Transplantation and Hepatectomy

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Montréal, Quebec, Canada, H2X 3J4
        • Centre hospitalier de l'Université de Montréal (CHUM)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patient undergoing hepatic surgery or liver transplantation

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
define the prevalence of systemic and cerebral desaturation phases during hepatic surgery or transplantation
Time Frame: from the beginning of anesthesia till 4 hours after the end of the surgery
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
Time Frame: duration of intensive care stay, an expected average of 4 days
duration of intensive care stay, an expected average of 4 days
validate the equivalence of the systemic and cerebral oxymetry
Time Frame: from the beginning of anesthesia till 4 hours after the end of the surgery
from the beginning of anesthesia till 4 hours after the end of the surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Collaborators

Medtronic - MITG
Centre de Recherche du Centre Hospitalier de l'Université de Montréal

Investigators

  • Principal Investigator: Franck Vandenbroucke-Menu, MD, Centre de Recherche du Centre Hospitalier de l'Université de Montréal
  • Principal Investigator: Réal Lapointe, MD-FRCS, Centre de Recherche du Centre Hospitalier de l'Université de Montréal
  • Principal Investigator: André Denault, MD PhD, Centre de Recherche du Centre Hospitalier de l'Université de Montréal

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2011

Primary Completion (Actual)

October 1, 2013

Study Completion (Actual)

January 1, 2014

Study Registration Dates

First Submitted

September 22, 2011

First Submitted That Met QC Criteria

October 20, 2011

First Posted (Estimate)

October 24, 2011

Study Record Updates

Last Update Posted (Estimate)

January 29, 2014

Last Update Submitted That Met QC Criteria

January 27, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CE10.192

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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