Swan-Ganz CCOmbo V for Obtaining an Optimal Depth of Righ... | NCT03544151

Studies
Swan-Ganz CCOmbo V for Obtaining an Optimal Depth of Right Internal Jugular Venous Catheter

NCT03544151

Sponsor

RenJi Hospital

Status

Completed

Last Update Posted

Mar 24, 2020Actual

Enrollment

105Actual

Phase

Not provided

Conditions

Insertion Depth of Central Venous Catheter

Interventions

Swan-Ganz Continuous Cardiac Output Thermodilutioon Cather (Swan-Ganz CCOmbo V)

Countries

China

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 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 10, 2018Actual

Primary Completion Date

Nov 25, 2019Actual

Completion Date

Dec 27, 2019Actual

First Submitted Date

May 21, 2018

First Submission Date that Met QC Criteria

May 31, 2018

First Posted Date

Jun 1, 2018Actual

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 22, 2020

Last Update Posted Date

Mar 24, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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

The investigators will perform a study to create formula for the optimal insertion depth of right internal jugular vein catheter.

Detailed Description

Patients scheduled for cardiac surgery were studied.Determine the optimal insertion depth of right internal jugular vein catheter using Swan-Ganz Continuous Cardiac Output Thermodilutioon Cather (Swan-Ganz CCOmbo V).The investigators measure the distance between the insertion point and the junction between right atrium and superior vena cava using Swan-Ganz CCOmbo V.

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

105Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Swan-Ganz Continuous Cardiac Output Thermodilutioon Cather (Swan-Ganz CCOmbo V)	Device	Swan-Ganz CCOmbo V insertion

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The distance	The distance between the insertion point and the junction between right atrium and superior vena cava	After insertion of the Swan-Ganz Continuous Cardiac Output Thermodilutioon Cather (Swan-Ganz CCOmbo V) and during operation

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adult patient over 18 years of age undergoing mitral valve or/and tricuspid valve
Surgery under general anesthesia, requiring Swan-Ganz Continuous Cardiac Output Thermodilutioon Cather (Swan-Ganz CCOmbo V) insertion through the right internal jugular vein.

Exclusion Criteria:

A change in the mediastinal structure from previous neck surgery,thoracic surgery or cardiac surgery
Extracardiac vascular anomaly
Anatomical abnormality in neck and thorax
Refusal to enrol

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients scheduled for cardiac surgery were studied

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
qi lu, Dr.	Renji Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, China	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Diansan Su		Shanghai	Shanghai Municipality	200127	China

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided