NeoplasmsNCT06004466
Noninvasive Internal Jugular Venous Oximetry
An observational study of Neoplasms, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
In this study, we are developing a novel plethysmographic monitoring device which incorporates several key techniques: inclusion of structural information (ultrasound image), coupling with the estimation of local tissue optical parameters, consideration of the tissue scattering absorption coefficient of each subject… Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Neoplasms
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- Sep 2023to Sep 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult cancer patients without organ dysfunction undergong planned central venous catheter placement for cancer surgery or totally implantable venous access device placement for future chemotherapy. During the central venous line placement, 3 ml blood sample from the internal jugular vein is obtained for internal validation of internal jugular venous saturation for our device.
Who may be able to join
- Patients undergoing major cancer surgery that requires central venous catheter placement
- Cancer patients undergoing totally implantable venous access device placement
Who cannot join
- Susepct infectious symptoms and signs (eg. white blood cell count count >10000 ; fever >38.3℃)
- impaired liver functions (aspartate aminotransferase> 100 U/L); impaired renal function (estimated glomerular filtration rate <60 mL/min/1.73 m2)
- heart failure, with New York Heart Associatation class 2 or more
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, 100
Chun-Yu Wu, 886976653376
About this study
Official title: The Development of Novel Noninvasive Internal Jugular Venous Oximetry
In this study, we are developing a novel plethysmographic monitoring device which incorporates several key techniques: inclusion of structural information (ultrasound image), coupling with the estimation of local tissue optical parameters, consideration of the tissue scattering absorption coefficient of each subject, to finally calculate the noninvasive continuous internal jugular venous saturation.
Read the detailed description
Central venous oxygen (ScvO2) is an important index for evaluating tissue perfusion in clinical care. To obtain the ScvO2 value, blood analysis must be obtained through a central venous catheter (CVC). Although CVC placement has a low incidence of complications, however, detrimental complications such as pneumothorax, hemothorax, infection and arrhythmia, are often fatal. In addition, continuous monitoring of ScvO2 often requires expensive equipment, so usually clinical caregivers can only take blood tests at specific care intervals, and may miss the opportunity to detect disease deterioration. In terms of anatomical structure and physiology, the values of internal jugular blood oxygen (SijvO2) and ScvO2 should be very close, and the evidence in the literature also points out that SijvO2 is not only highly similar to ScvO2, but also related to changes in cerebral blood oxygen. The internal jugular vein location is also an easier location for non-invasive continuous monitoring and thus it is interested to develop the novel technique for noninvasive continuous SijvO2 monitoring.
In this study, we are developing a novel plethysmographic monitoring device which incorporates several key techniques: inclusion of structural information (ultrasound image), coupling with the estimation of local tissue optical parameters, consideration of the tissue scattering absorption coefficient of each subject, to finally calculate the noninvasive continuous internal jugular venous saturation.
- Conditions
- Neoplasms
- Medical subject headings
- Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Internal jugular venous saturation
To validate the estimation of noninvasive internal jugular venous saturation and the real value by obtaing the internal jugular venous blood during central venous catheter placement
Measured: 20 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2023
- Study startSep 2023 (estimated)
- Primary completionSep 2024 (estimated)
- Study completionSep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeoplasmsStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chun-Yu Wu, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06004466
- Sponsor's protocol ID
- 202203103DIND
- Status last verified
- Aug 2023
- First submitted
- 17 Aug 2023
- Last updated
- 22 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Development of Novel Noninvasive Internal Jugular Venous Oximetry
- ClinicalTrials.gov ID
- NCT06004466
- Acronym / sponsor ID
- 202203103DIND
- Conditions
- Neoplasms
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Sep 2023 (estimated)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 22 Aug 2023 (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.
In this study, we are developing a novel plethysmographic monitoring device which incorporates several key techniques: inclusion of structural information (ultrasound image), coupling with the estimation of local tissue optical parameters, consideration of the tissue scattering absorption coefficient of each subject, to finally calculate the noninvasive continuous internal jugular venous saturation.
Detailed description
Central venous oxygen (ScvO2) is an important index for evaluating tissue perfusion in clinical care. To obtain the ScvO2 value, blood analysis must be obtained through a central venous catheter (CVC). Although CVC placement has a low incidence of complications, however, detrimental complications such as pneumothorax, hemothorax, infection and arrhythmia, are often fatal. In addition, continuous monitoring of ScvO2 often requires expensive equipment, so usually clinical caregivers can only take blood tests at specific care intervals, and may miss the opportunity to detect disease deterioration. In terms of anatomical structure and physiology, the values of internal jugular blood oxygen (SijvO2) and ScvO2 should be very close, and the evidence in the literature also points out that SijvO2 is not only highly similar to ScvO2, but also related to changes in cerebral blood oxygen. The internal jugular vein location is also an easier location for non-invasive continuous monitoring and thus it is interested to develop the novel technique for noninvasive continuous SijvO2 monitoring.
In this study, we are developing a novel plethysmographic monitoring device which incorporates several key techniques: inclusion of structural information (ultrasound image), coupling with the estimation of local tissue optical parameters, consideration of the tissue scattering absorption coefficient of each subject, to finally calculate the noninvasive continuous internal jugular venous saturation.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult cancer patients without organ dysfunction undergong planned central venous catheter placement for cancer surgery or totally implantable venous access device placement for future chemotherapy. During the central venous line placement, 3 ml blood sample from the internal jugular vein is obtained for internal validation of internal jugular venous saturation for our device.
Key inclusion criteria (2 listed)
- Patients undergoing major cancer surgery that requires central venous catheter placement
- Cancer patients undergoing totally implantable venous access device placement
Key exclusion criteria (3 listed)
- Susepct infectious symptoms and signs (eg. white blood cell count count >10000 ; fever >38.3℃)
- impaired liver functions (aspartate aminotransferase> 100 U/L); impaired renal function (estimated glomerular filtration rate <60 mL/min/1.73 m2)
- heart failure, with New York Heart Associatation class 2 or more
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
Internal jugular venous saturation
Time frame: 20 min
To validate the estimation of noninvasive internal jugular venous saturation and the real value by obtaing the internal jugular venous blood during central venous catheter placement
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2023.
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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.
Chun-Yu Wu principal investigator
National Taiwan University Hospital
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 Neoplasms, run by National Taiwan University Hospital at 1 site in Taiwan.
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 3 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: status not confirmed, as of the sponsor's last update on 22 Aug 2023. 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 Taiwan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chun-Yu Wu (886976653376, b001089018@tmu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Internal jugular venous saturation (time frame: 20 min). 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 22 Aug 2023.