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Completed

NCT Number: NCT04624009

Non-Invasive Measurement of SjvO2 Using Near Infrared Spectroscopy in Critically Ill Patients

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Geneva, Geneva, Switzerland

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About this study

ScvO2 measures central venous oxygen saturation level from veins draining the head and upper body while SvO2 measures mixed venous oxygen saturation from the lower and upper half of the body. ScvO2 is more conveniently measured and less risky than Sv02 measurement although a central venous catheter is needed. ScvO2 gives knowledge about the balance between the delivery of oxygen and oxygen consumption in the body. Interest in ScvO2 monitoring in anesthesia and critical care has been debated. However, ScvO2 is still recommended as a major hemodynamic target of early resuscitation of critically ill patients. Even if ScvO2 measurement is far less invasive than SvO2 measurement through pulmonary artery catheter, it is accompanied with morbidity.

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 ScvO2 in order to possibly use in the future SjvO2 measured by VO 100 as a noninvasive surrogate of ScvO2.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. Comparison of venous oxygen saturation 1

    Time frame: On admission to the intensive care unit

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

Secondary outcomes

  1. Comparison of venous oxygen saturation 2

    Time frame: 3 days after admission into the intensive care unit

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

  2. Comparison of venous oxygen saturation 3

    Time frame: On admission to internal medicine ward

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

Sponsors and collaborators

Lead sponsor

University Hospital, Geneva

Other

Registry information

Official study title

Relationship Between Near Infrared Spectroscopy Jugular Venous Oxygen Saturation (SjvO2) and Central Venous Saturation of Oxygen (ScvO2) in Critically Ill Patients.

Acronym: NIRS-SCJVO2

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Nov 10, 2020
Registry last updated
Nov 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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