NCT04624009

Brief Summary

ScvO2 is an important parameter in the management of critically ill patient. The only way to measure it is to have an internal jugular or subclavian central venous catheter. With this trial, the investigators want to show a positive relationship between invasive ScvO2 measurement and noninvasive SjvO2 measurement with VO 100 medical device from Mespere LifeSciences, allowing the use of SjvO2 as a noninvasive surrogate of ScvO2 in critically ill patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
35

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2022

Geographic Reach
1 country

2 active sites

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

August 7, 2020

Completed
3 months until next milestone

First Posted

Study publicly available on registry

November 10, 2020

Completed
1.1 years until next milestone

Study Start

First participant enrolled

January 1, 2022

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2023

Completed
Last Updated

November 29, 2023

Status Verified

May 1, 2022

Enrollment Period

1.2 years

First QC Date

August 7, 2020

Last Update Submit

November 28, 2023

Conditions

Keywords

Brain oxygen deliveryJugular Venous Oxygen SaturationCentral Venous Oxygen SaturationMedical Device Use

Outcome Measures

Primary Outcomes (1)

  • Comparison of venous oxygen saturation 1

    Comparison of ScvO2 values from CVC blood sample and SjvO2 values from the VO 100 (% oxygen saturation)

    On admission to the intensive care unit

Secondary Outcomes (2)

  • Comparison of venous oxygen saturation 2

    3 days after admission into the intensive care unit

  • Comparison of venous oxygen saturation 3

    On admission to internal medicine ward

Eligibility Criteria

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

ICU adult patients routinely equipped with a central venous catheter placed in internal jugular or subclavian vein

You may qualify if:

  • all ICU adult patients routinely equipped with a central venous catheter placed in internal jugular or subclavian vein allowing ScvO2 measurement from blood sampling.
  • The investigators will perform this study only on patients already equipped with an internal jugular CVC. In other words, the placement of the CVC is not conditioned by the study realization.

You may not qualify if:

  • patients with CVC placed in another site than internal jugular vein.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Geneva

Geneva, 1211, Switzerland

Location

Eduardo Schiffer

Veyrier, 1255, Switzerland

Location

Study Design

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

Study Record Dates

First Submitted

August 7, 2020

First Posted

November 10, 2020

Study Start

January 1, 2022

Primary Completion

April 1, 2023

Study Completion

August 1, 2023

Last Updated

November 29, 2023

Record last verified: 2022-05

Locations