- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02456259
Postoperative Patency of Internal Jugular Vein After Neck Cannula Insertion
July 22, 2019 updated by: Zdenek Turek, University Hospital Hradec Kralove
Postoperative Patency of Internal Jugular Vein After Neck Cannula Insertion in Patients Undergoing Minimally Invasive Cardiac Surgery
The number of patients undergoing Minimally Invasive Cardiac Surgery (MICS) is increasing each year.
MICS procedures on atrioventricular valves are usually performed without conventional sternotomy, an alternative approach is from right anterolateral minithoracotomy.
This surgical approach has essential impact both on anesthesia techniques and cardiopulmonary bypass (CPB) settings.
Specific anesthesiological procedure is an insertion of neck venous cannula of CPB through the right internal jugular vein into the superior vena cava both for partial and total bypass.
The size of neck cannula is between 15 and 21 French depending on the type of surgical procedure and patient's weight.
Central venous catheter and eventually sheath are also inserted into the right internal jugular vein.
Thus, there is a relevant question regarding postoperative patency of right internal jugular vein in patients undergoing MICS procedures requiring an insertion of neck cannula of CPB.
The investigators hypothesize, there is no significant difference in postoperative patency of internal jugular vein assessed by ultrasound in patient undergoing cardiac surgery with and without neck cannula of CPB
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Anticipated)
110
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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Hradec Kralove, Czechia, 50005
- University Hospital Hradec Kralove
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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
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Adult patients undergoing cardiac surgery both from conventional sternotomy without neck cannula and from right mini thoracothomy reguiring neck cannula insertion into right internal jugular vein.
Description
Inclusion Criteria:
adult patients undergoing cardiac surgery
- conventional sternotomy without neck cannula as planned operating approach
- right minithoracotomy with neck cannula as planned operating approach
Exclusion Criteria:
- Any pathology of right internal jugular vein on preoperative ultrasound (vein not fully compressible, hypoplastic jugular vein, preoperative invasion on right jugular vein)
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: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Neck cannula group
Patients in this group are indicated for neck cannula insertion due to tzpu of cardiac surgery (MICS)
|
Neck cannula insertion is necessary for establishing of cardiopulmonary bypass for Minimally Invasive Cardiac Surgery.
It is routine procedure for this type of cardiac surgery.
|
Central venous catheter only group
Patients in this group are indicated for central venous catheter insertion only.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Postoperative patency of internal jugular vein
Time Frame: 7 days
|
Comparison of ultrasound findings on right internal jugular vein preoperatively and 7 days after operation
|
7 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Zdenek Turek, MD, Ph.D., University Hospital Hradec Kralove, Dept. of Anesthesiology, Sokolska 581, Hradec Kralove, 50005, Czech Republic
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Vernick WJ, Woo JY. Anesthetic considerations during minimally invasive mitral valve surgery. Semin Cardiothorac Vasc Anesth. 2012 Mar;16(1):11-24. doi: 10.1177/1089253211434591. Epub 2012 Feb 22.
- Brass P, Hellmich M, Kolodziej L, Schick G, Smith AF. Ultrasound guidance versus anatomical landmarks for internal jugular vein catheterization. Cochrane Database Syst Rev. 2015 Jan 9;1(1):CD006962. doi: 10.1002/14651858.CD006962.pub2.
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)
June 1, 2015
Primary Completion (Actual)
July 1, 2019
Study Completion (Actual)
July 1, 2019
Study Registration Dates
First Submitted
May 24, 2015
First Submitted That Met QC Criteria
May 27, 2015
First Posted (Estimate)
May 28, 2015
Study Record Updates
Last Update Posted (Actual)
July 23, 2019
Last Update Submitted That Met QC Criteria
July 22, 2019
Last Verified
July 1, 2019
More Information
Terms related to this study
Other Study ID Numbers
- 201504S17P
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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