Correlation Between External Jugular Venous and Superior... | NCT04017182

Studies
Correlation Between External Jugular Venous and Superior Vena Cava Central Venous Blood Oxygen Saturation in Patient Under General Anesthesia

NCT04017182

Sponsor

Ramathibodi Hospital

Status

Unknown status

Last Update Posted

Mar 9, 2021Actual

Enrollment

40Estimated

Phase

Not provided

Conditions

Central Venous Oxygen Saturation

Interventions

Not provided

Countries

Thailand

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1, 2021Estimated

Primary Completion Date

Dec 1, 2021Estimated

Completion Date

Dec 1, 2021Estimated

First Submitted Date

Jul 4, 2019

First Submission Date that Met QC Criteria

Jul 11, 2019

First Posted Date

Jul 12, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 5, 2021

Last Update Posted Date

Mar 9, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

All patients age between 18-65 year old who undergoing surgery under general anesthesia and superior vena cava central venous catheter installation anticipated are eligible. The tips of superior vena cava central venous catheter was confirmed by Chest x-ray. Next 1 hour after skin incision, 1 ml of venous blood sample is taken from superior vena cava central venous catheter of right external jugular vein then send to central laboratory for venous blood gas analysis. The demographic data will be recorded. Correlation between superior vena cava central venous blood and right external jugular venous blood oxygen saturation will be determined the primary outcome and partial pressure of carbon dioxide will be determined as a secondary outcome.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Correlation of venous oxygen saturation	Correlation of venous oxygen saturation between external jugular vein and superior vena cava	1 hour

Secondary Outcomes

Measure	Description	Time Frame
Correlation of venous partial pressure of carbon dioxide	Correlation of venous partial pressure of carbon dioxide between external jugular vein and superior vena cava	1 hour
Relationship between superior vena cava central venous and external jugular venous oxygen saturation

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Thanist Pravitharangul, MD	Contact	66866633694		thnst_yu@msn.com
Cherdkiat Karnjanarachata, MD	Contact	66855774747		chird_na@yahoo.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Anesthesiology, Ramathibodi Hospital		Bangkok	Bangkok	10400	Thailand

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided