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Clinical Trials/NCT06004466
NCT06004466
Recruiting
N/A

The Development of Novel Noninvasive Internal Jugular Venous Oximetry

National Taiwan University Hospital1 site in 1 country100 target enrollmentSeptember 2023
ConditionsNeoplasms

Overview

Phase
N/A
Intervention
Not specified
Conditions
Neoplasms
Sponsor
National Taiwan University Hospital
Enrollment
100
Locations
1
Primary Endpoint
Internal jugular venous saturation
Status
Recruiting
Last Updated
2 years ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
September 2023
End Date
September 2024
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility 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

Outcomes

Primary Outcomes

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

Study Sites (1)

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