Impaired Oxygen DeliveryNCT04778150
Non-Invasive Measurement of SjvO2 Using Near Infrared Spectroscopy in Patients Undergoing Liver Transplantation Surgery
An observational study of Impaired Oxygen Delivery and Transplant; Failure, Liver, run by University Hospital, Geneva at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Impaired Oxygen Delivery, Transplant; Failure, Liver
- What is being tested?
- VO 100 medical device from Mespere LifeSciences
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Jun 2023to 30 Jan 2024
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients undergoing liver transplantation surgery for whom measurement of SvO2 is required especially during portal vein clamping.
Who may be able to join
- Adult patients routinely equipped with a pulmonary artery catheter just before liver transplantation surgery allowing SvO2 measurement.
Who cannot join
- Adult patients not equipped with pulmonary artery catheter for liver transplantation surgery.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- VO 100 medical device from Mespere LifeSciences
- Keywords
- SvO2, SjvO2, Portal vein clamping, Liver transplantation surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VO 100 medical device from Mespere LifeSciencesDevice
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of venous oxygen saturation
Comparison of SvO2 values from pulmonary artery catheter blood and SjvO2 values from the VO 100 (% oxygen saturation)
Measured: Continuously during liver transplantation surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2021
- Study start1 Jun 2023
- Primary completion30 Oct 2023
- Study completion30 Jan 2024
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
- 20 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
- Investigators
- Eduardo Schiffer, MD, Principal investigator, Head of anesthesia for liver transplantation surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04778150
- Sponsor's protocol ID
- SJVO2 vs SVO2
- Status last verified
- May 2022
- First submitted
- 26 Feb 2021
- Last updated
- 8 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04778150
- Acronym / sponsor ID
- SJVO2 vs SVO2
- Keywords
- SvO2, SjvO2, Portal vein clamping, Liver transplantation surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 30 Oct 2023 (actual)
- Study completion
- 30 Jan 2024 (actual)
- First posted
- 2 Mar 2021 (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.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients undergoing liver transplantation surgery for whom measurement of SvO2 is required especially during portal vein clamping.
Key inclusion criteria (1 listed)
- Adult patients routinely equipped with a pulmonary artery catheter just before liver transplantation surgery allowing SvO2 measurement.
Key exclusion criteria (1 listed)
- Adult patients not equipped with pulmonary artery catheter for liver transplantation surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VO 100 medical device from Mespere LifeSciencesThe 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. | Device | – |
Primary outcome
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)
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 8 May 2024.
- Individual participant dataSharing planned: No
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.
Eduardo Schiffer, MD principal investigator
Head of anesthesia for liver transplantation surgery
1 site 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 Transplant; Failure, Liver, run by University Hospital, Geneva at 1 site 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 1 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 8 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 (time frame: Continuously during liver transplantation surgery). 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 8 May 2024.