NCT04778150

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 26, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 2, 2021

Completed
2.2 years until next milestone

Study Start

First participant enrolled

June 1, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2024

Completed
Last Updated

May 8, 2024

Status Verified

May 1, 2022

Enrollment Period

5 months

First QC Date

February 26, 2021

Last Update Submit

May 7, 2024

Conditions

Keywords

SvO2SjvO2Portal vein clampingLiver transplantation surgery

Outcome Measures

Primary Outcomes (1)

  • Comparison of venous oxygen saturation

    Comparison of SvO2 values from pulmonary artery catheter blood and SjvO2 values from the VO 100 (% oxygen saturation)

    Continuously during liver transplantation surgery

Interventions

The investigators want 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 in patients undergoing liver transplantation surgery.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Geneva

Geneva, 1211, Switzerland

Location

Study Officials

  • Eduardo Schiffer, MD

    Head of anesthesia for liver transplantation surgery

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

February 26, 2021

First Posted

March 2, 2021

Study Start

June 1, 2023

Primary Completion

October 30, 2023

Study Completion

January 30, 2024

Last Updated

May 8, 2024

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations