NCT02456259

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 24, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 28, 2015

Completed
4 days until next milestone

Study Start

First participant enrolled

June 1, 2015

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2019

Completed
Last Updated

July 23, 2019

Status Verified

July 1, 2019

Enrollment Period

4.1 years

First QC Date

May 24, 2015

Last Update Submit

July 22, 2019

Conditions

Keywords

internal jugular vein patencyMICSneck cannulaJugular veins

Outcome Measures

Primary Outcomes (1)

  • Postoperative patency of internal jugular vein

    Comparison of ultrasound findings on right internal jugular vein preoperatively and 7 days after operation

    7 days

Study Arms (2)

Neck cannula group

Patients in this group are indicated for neck cannula insertion due to tzpu of cardiac surgery (MICS)

Procedure: Neck cannula insertion

Central venous catheter only group

Patients in this group are indicated for central venous catheter insertion only.

Interventions

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.

Neck cannula group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • adult patients undergoing cardiac surgery
  • conventional sternotomy without neck cannula as planned operating approach
  • right minithoracotomy with neck cannula as planned operating approach

You may not qualify if:

  • Any pathology of right internal jugular vein on preoperative ultrasound (vein not fully compressible, hypoplastic jugular vein, preoperative invasion on right jugular vein)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Hradec Kralove

Hradec Králové, 50005, Czechia

Location

Related Publications (2)

  • 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.

    PMID: 22361820BACKGROUND
  • 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.

    PMID: 25575244BACKGROUND

Study Officials

  • Zdenek Turek, MD, Ph.D.

    University Hospital Hradec Kralove, Dept. of Anesthesiology, Sokolska 581, Hradec Kralove, 50005, Czech Republic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Ph.D.

Study Record Dates

First Submitted

May 24, 2015

First Posted

May 28, 2015

Study Start

June 1, 2015

Primary Completion

July 1, 2019

Study Completion

July 1, 2019

Last Updated

July 23, 2019

Record last verified: 2019-07

Locations