Noninvasive Internal Jugular Venous Oximetry

Sponsor
National Taiwan University Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT06004466
Collaborator
(none)
100
1
12
8.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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

    Study Type:
    Observational
    Anticipated Enrollment :
    100 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    The Development of Novel Noninvasive Internal Jugular Venous Oximetry
    Anticipated Study Start Date :
    Sep 1, 2023
    Anticipated Primary Completion Date :
    Sep 1, 2024
    Anticipated Study Completion Date :
    Sep 1, 2024

    Outcome Measures

    Primary Outcome Measures

    1. Internal jugular venous saturation [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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 National Taiwan University Hospital Taipei Taiwan 100

    Sponsors and Collaborators

    • National Taiwan University Hospital

    Investigators

    • Principal Investigator: Chun-Yu Wu, National Taiwan University Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    National Taiwan University Hospital
    ClinicalTrials.gov Identifier:
    NCT06004466
    Other Study ID Numbers:
    • 202203103DIND
    First Posted:
    Aug 22, 2023
    Last Update Posted:
    Aug 22, 2023
    Last Verified:
    Aug 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Aug 22, 2023