Impaired Oxygen DeliveryNIRS-SCJVO2NCT04624009
Non-Invasive Measurement of SjvO2 Using Near Infrared Spectroscopy in Critically Ill Patients
An observational study of Impaired Oxygen Delivery and Critically Ill Patient, run by University Hospital, Geneva at 2 sites in Switzerland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Impaired Oxygen Delivery, Critically Ill Patient
- How many people
- 35 participants
- Where
- 2 sitesSwitzerland
- Study dates
- 1 Jan 2022to 1 Aug 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: ICU adult patients routinely equipped with a central venous catheter placed in internal jugular or subclavian vein
Who may be able to join
- 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.
Who cannot join
- patients with CVC placed in another site than internal jugular vein.
Trial locations and contacts
2 sites in 1 country.
Switzerland2 sites
University of Geneva
Geneva, 1211
Eduardo Schiffer
Veyrier, 1255
About this study
Official title: Relationship Between Near Infrared Spectroscopy Jugular Venous Oxygen Saturation (SjvO2) and Central Venous Saturation of Oxygen (ScvO2) 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.
Read the detailed description
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.
- Conditions
- Impaired Oxygen Delivery, Critically Ill Patient
- Keywords
- Brain oxygen delivery, Jugular Venous Oxygen Saturation, Central Venous Oxygen Saturation, Medical Device Use
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of venous oxygen saturation 1
Comparison of ScvO2 values from CVC blood sample and SjvO2 values from the VO 100 (% oxygen saturation)
Measured: On admission to the intensive care unit
Secondary outcomes (2)
Comparison of venous oxygen saturation 2
Comparison of ScvO2 values from CVC blood sample and SjvO2 values from the VO 100 (% oxygen saturation)
Measured: 3 days after admission into the intensive care unit
Comparison of venous oxygen saturation 3
Comparison of ScvO2 values from CVC blood sample and SjvO2 values from the VO 100 (% oxygen saturation)
Measured: On admission to internal medicine ward
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2020
- Study start1 Jan 2022
- Primary completion1 Apr 2023
- Study completion1 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Impaired Oxygen DeliveryStudies of the same condition, open and under way.
- More trials run by University Hospital, GenevaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eduardo Schiffer, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04624009
- Sponsor's protocol ID
- SjvO2 vs ScvO2 / HUG-DMA
- Acronym
- NIRS-SCJVO2
- Status last verified
- May 2022
- First submitted
- 7 Aug 2020
- Last updated
- 29 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Near Infrared Spectroscopy Jugular Venous Oxygen Saturation (SjvO2) and Central Venous Saturation of Oxygen (ScvO2) in Critically Ill Patients.
- ClinicalTrials.gov ID
- NCT04624009
- Acronym / sponsor ID
- NIRS-SCJVO2 / SjvO2 vs ScvO2 / HUG-DMA
- Conditions
- Impaired Oxygen Delivery, Critically Ill Patient
- Keywords
- Brain oxygen delivery, Jugular Venous Oxygen Saturation, Central Venous Oxygen Saturation, Medical Device Use
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Apr 2023 (actual)
- Study completion
- 1 Aug 2023 (actual)
- First posted
- 10 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- ICU adult patients routinely equipped with a central venous catheter placed in internal jugular or subclavian vein
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- patients with CVC placed in another site than internal jugular vein.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
2 secondary outcomes
Comparison of venous oxygen saturation 2
Time frame: 3 days after admission into the intensive care unit
Comparison of venous oxygen saturation 3
Time frame: On admission to internal medicine ward
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2023.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Impaired Oxygen Delivery and Critically Ill Patient, run by University Hospital, Geneva at 2 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of venous oxygen saturation 1 (time frame: On admission to the intensive care unit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2023.