Noninvasive Internal Jugular Venous Oximetry

NCT ID: NCT06004466

Last Updated: 2023-08-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-09-30

Study Completion Date

2024-09-30

Brief Summary

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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

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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

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Neoplasms

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Chun-Yu Wu

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University Hospital

Locations

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National Taiwan University Hospital

Taipei, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Chun-Yu Wu

Role: CONTACT

886976653376

Facility Contacts

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Chun-Yu Wu

Role: primary

886976653376

Other Identifiers

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202203103DIND

Identifier Type: -

Identifier Source: org_study_id

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