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Trial Title:
Noninvasive Internal Jugular Venous Oximetry
NCT ID:
NCT06004466
Condition:
Neoplasms
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
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, 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.
Criteria for eligibility:
Study pop:
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.
Sampling method:
Probability Sample
Criteria:
Inclusion Criteria:
- Patients undergoing major cancer surgery that requires central venous catheter
placement
- Cancer patients undergoing totally implantable venous access device placement
Exclusion Criteria:
- 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
Gender:
All
Minimum age:
20 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
National Taiwan University Hospital
Address:
City:
Taipei
Zip:
100
Country:
Taiwan
Status:
Recruiting
Contact:
Last name:
Chun-Yu Wu
Phone:
886976653376
Start date:
September 2023
Completion date:
September 2024
Lead sponsor:
Agency:
National Taiwan University Hospital
Agency class:
Other
Source:
National Taiwan University Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06004466
