NCT06004466

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 17, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 22, 2023

Completed
10 days until next milestone

Study Start

First participant enrolled

September 1, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2024

Completed
Last Updated

August 22, 2023

Status Verified

August 1, 2023

Enrollment Period

1 year

First QC Date

August 17, 2023

Last Update Submit

August 17, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

    20 min

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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.

You may qualify if:

  • Patients undergoing major cancer surgery that requires central venous catheter placement
  • Cancer patients undergoing totally implantable venous access device placement

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

RECRUITING

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Chun-Yu Wu

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 17, 2023

First Posted

August 22, 2023

Study Start

September 1, 2023

Primary Completion

September 1, 2024

Study Completion

September 1, 2024

Last Updated

August 22, 2023

Record last verified: 2023-08

Locations