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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02456259
Other study ID # 201504S17P
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 1, 2015
Est. completion date July 1, 2019

Study information

Verified date July 2019
Source University Hospital Hradec Kralove
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


Recruitment information / eligibility

Status Completed
Enrollment 110
Est. completion date July 1, 2019
Est. primary completion date July 1, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- adult patients undergoing cardiac surgery

1. conventional sternotomy without neck cannula as planned operating approach

2. 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 Design


Related Conditions & MeSH terms


Intervention

Procedure:
Neck cannula insertion
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.

Locations

Country Name City State
Czechia University Hospital Hradec Kralove Hradec Kralove

Sponsors (1)

Lead Sponsor Collaborator
University Hospital Hradec Kralove

Country where clinical trial is conducted

Czechia, 

References & Publications (2)

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:CD006962. doi: 10.1002/14651858.CD006962.pub2. Review. — View Citation

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. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Postoperative patency of internal jugular vein Comparison of ultrasound findings on right internal jugular vein preoperatively and 7 days after operation 7 days
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