NCT04017182

Brief Summary

After installation of central venous catheter in patients under general anesthesia, paired sample of superior vena cava central venous blood and right external jugular venous blood will be collected and send to central laboratory for venous blood gas analysis. Correlation between superior vena cava central venous blood and right external jugular venous blood oxygen saturation will be determined as primary outcome.

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
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2021

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

July 4, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 12, 2019

Completed
1.7 years until next milestone

Study Start

First participant enrolled

April 1, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

March 9, 2021

Status Verified

March 1, 2021

Enrollment Period

8 months

First QC Date

July 4, 2019

Last Update Submit

March 5, 2021

Conditions

Keywords

central venous oxygen saturationexternal jugular venous oxygen saturationcentral venous catheterexternal jugular veininternal jugular veinsuperior vena cava oxygen saturation

Outcome Measures

Primary Outcomes (1)

  • Correlation of venous oxygen saturation

    Correlation of venous oxygen saturation between external jugular vein and superior vena cava

    1 hour

Secondary Outcomes (2)

  • Correlation of venous partial pressure of carbon dioxide

    1 hour

  • Relationship between superior vena cava central venous and external jugular venous oxygen saturation

    1 hour

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult surgical patients undergoing surgery under general anesthesia in institutional operating theaters with superior vena cava central venous catheter installation anticipated.

You may qualify if:

  • Written consent obtained from patient or next of kin a day before operation date
  • Patient age between 18-65 years old undergoing syrgery under general anesthesia
  • Superior vena cava central venous catheter anticipated for CVP mesurement, innotropic or vasopressor administration,pulmonary artery catheter insertion route
  • Anticipated right external jugular venous sampling time less than 5 minutes
  • The site of blood sample collection easily access during operation

You may not qualify if:

  • No jugular central venous catheter installation or other route selected
  • Duration of paired sample collection more than 10 minutes
  • Can not collected blood sample from right external jugular vein within 3 attemps
  • The site of blood sample collection difficulty access during operation
  • Pateint or next of kin refuse to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesiology, Ramathibodi Hospital

Bangkok, Bangkok, 10400, Thailand

Location

Central Study Contacts

Thanist Pravitharangul, MD

CONTACT

Cherdkiat Karnjanarachata, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

July 4, 2019

First Posted

July 12, 2019

Study Start

April 1, 2021

Primary Completion

December 1, 2021

Study Completion

December 1, 2021

Last Updated

March 9, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations