- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03544151
Swan-Ganz CCOmbo V for Obtaining an Optimal Depth of Right Internal Jugular Venous Catheter
March 22, 2020 updated by: RenJi Hospital
Swan-Ganz CCOmbo V for Obtaining an Optimal Depth of Right Internal Jugular Venous Catheter : A Prospective Observational Study
The investigators will perform a study to create formula for the optimal insertion depth of right internal jugular vein catheter.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Observational
Enrollment (Actual)
105
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Shanghai
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Shanghai, Shanghai, China, 200127
- Diansan Su
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Patients scheduled for cardiac surgery were studied
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The distance
Time Frame: After insertion of the Swan-Ganz Continuous Cardiac Output Thermodilutioon Cather (Swan-Ganz CCOmbo V) and during operation
|
The distance between the insertion point and the junction between right atrium and superior vena cava
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After insertion of the Swan-Ganz Continuous Cardiac Output Thermodilutioon Cather (Swan-Ganz CCOmbo V) and during operation
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: qi lu, Dr., Renji Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, China
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 10, 2018
Primary Completion (Actual)
November 25, 2019
Study Completion (Actual)
December 27, 2019
Study Registration Dates
First Submitted
May 21, 2018
First Submitted That Met QC Criteria
May 31, 2018
First Posted (Actual)
June 1, 2018
Study Record Updates
Last Update Posted (Actual)
March 24, 2020
Last Update Submitted That Met QC Criteria
March 22, 2020
Last Verified
March 1, 2020
More Information
Terms related to this study
Other Study ID Numbers
- 2018-012
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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