Non-Invasive Measurement of SjvO2 Using Near Infrared Spectroscopy in Patients Undergoing Liver Transplantation Surgery

May 7, 2024 updated by: Eduardo Schiffer, University Hospital, Geneva

Relationship Between Non-Invasive Measurement of Jugular Venous Oxygen Saturation (SjvO2) Using Near Infraread Spectroscopy and Measurement of Mixed Venous Saturation of Oxygen (SvO2) in Patients Undergoing Liver Transplantation Surgery

Mixed venous oxygen saturation (SvO2) is an important parameter in the management of patient during liver transplantation surgery especially during portal vein clamping. The only way to measure it is to use a pulmonary artery catheter. If the authors can show a positive relationship between invasive SvO2 measurement and noninvasive jugular venous oxygen saturation (SjvO2) measurement with VO 100 medical device, it will possible to use SjvO2 as a noninvasive surrogate of SvO2 in patients during liver transplantation surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

SvO2 measures mixed venous oxygen saturation from the lower and upper half of the body. To be measured, Sv02 requires a central venous catheter. SvO2 gives knowledge about the balance between the delivery of oxygen and oxygen consumption in the body. Interest in SvO2 monitoring in anesthesia and critical care has been debated. However, SvO2 is still recommended as a major hemodynamic target of early resuscitation of critically ill patients. SvO2 measurement through pulmonary artery catheter is accompanied with morbidity due to its invasiveness. During liver transplantation surgery, measurement of SvO2 is required to adequately manage hemodynamics of the patient, especially during portal venous clamping.

VO 100 medical device from Mespere LifeSciences allows a non-invasive measurement of SjvO2 using the NIRS technique. Jugular venous oxygen saturation (SjvO2) is a measurement of the amount of oxygen left in the venous system after the brain has removed the oxygen that it needs.

On the same principle that a positive relationship between ScvO2 and SvO2 has been shown, what the investigators are trying to do is to show a positive relationship between SjvO2 and SvO2 in order to possibly use in the future SjvO2 measured by VO 100 as a noninvasive surrogate of SvO2 during liver transplantation surgery.

Study Type

Observational

Enrollment (Actual)

20

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

  • Switzerland
      • Geneva, Switzerland, 1211
        • University of Geneva

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

Sampling Method

Probability Sample

Study Population

Adult patients undergoing liver transplantation surgery for whom measurement of SvO2 is required especially during portal vein clamping.

Description

Inclusion Criteria:

  • Adult patients routinely equipped with a pulmonary artery catheter just before liver transplantation surgery allowing SvO2 measurement.

Exclusion Criteria:

  • Adult patients not equipped with pulmonary artery catheter for liver transplantation surgery.

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
Measure Description
Time Frame
Comparison of venous oxygen saturation
Time Frame: Continuously during liver transplantation surgery
Comparison of SvO2 values from pulmonary artery catheter blood and SjvO2 values from the VO 100 (% oxygen saturation)
Continuously during liver transplantation surgery

Collaborators and Investigators

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

Sponsor

University Hospital, Geneva

Investigators

  • Principal Investigator: Eduardo Schiffer, MD, Head of anesthesia for liver transplantation surgery

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 (Actual)

June 1, 2023

Primary Completion (Actual)

October 30, 2023

Study Completion (Actual)

January 30, 2024

Study Registration Dates

First Submitted

February 26, 2021

First Submitted That Met QC Criteria

February 26, 2021

First Posted (Actual)

March 2, 2021

Study Record Updates

Last Update Posted (Actual)

May 8, 2024

Last Update Submitted That Met QC Criteria

May 7, 2024

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • SJVO2 vs SVO2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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