Cardiac Surgical ProcedureNCT02456259
Postoperative Patency of Internal Jugular Vein After Neck Cannula Insertion
An observational study of Cardiac Surgical Procedure, run by University Hospital Hradec Kralove at 1 site in Czechia.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Surgical Procedure
- What is being tested?
- Neck cannula insertion
- Type of treatment
- Surgery or procedure
- How many people
- 110 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Jun 2015to 1 Jul 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- adult patients undergoing cardiac surgery
- conventional sternotomy without neck cannula as planned operating approach
- right minithoracotomy with neck cannula as planned operating approach
Who cannot join
- Any pathology of right internal jugular vein on preoperative ultrasound (vein not fully compressible, hypoplastic jugular vein, preoperative invasion on right jugular vein)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
- Conditions
- Cardiac Surgical Procedure
- Being tested
- Neck cannula insertion
- Keywords
- internal jugular vein patency, MICS, neck cannula, Jugular veins
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neck cannula insertionProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Neck cannula group | Patients in this group are indicated for neck cannula insertion due to tzpu of cardiac surgery (MICS) Receives: Procedure: Neck cannula insertion | |
| Central venous catheter only group | Patients in this group are indicated for central venous catheter insertion only. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative patency of internal jugular vein
Comparison of ultrasound findings on right internal jugular vein preoperatively and 7 days after operation
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2015 (estimated)
- Study start1 Jun 2015
- Primary completion1 Jul 2019
- Study completion1 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cardiac Surgical ProcedureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Hradec Kralove
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zdenek Turek, University Hospital Hradec Kralove
- Investigators
- Zdenek Turek, MD, Ph.D., Principal investigator, University Hospital Hradec Kralove, Dept. of Anesthesiology, Sokolska 581, Hradec Kralove, 50005, Czech Republic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02456259
- Sponsor's protocol ID
- 201504S17P
- Status last verified
- Jul 2019
- First submitted
- 24 May 2015
- Last updated
- 23 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 22361820Brass 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.
PubMed 25575244
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Patency of Internal Jugular Vein After Neck Cannula Insertion in Patients Undergoing Minimally Invasive Cardiac Surgery
- ClinicalTrials.gov ID
- NCT02456259
- Acronym / sponsor ID
- 201504S17P
- Conditions
- Cardiac Surgical Procedure
- Keywords
- internal jugular vein patency, MICS, neck cannula, Jugular veins
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- University Hospital Hradec KraloveUniversity, hospital or other
- Study start
- 1 Jun 2015 (actual)
- Primary completion
- 1 Jul 2019 (actual)
- Study completion
- 1 Jul 2019 (actual)
- First posted
- 28 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neck cannula group | – | Procedure: Neck cannula insertionPatients in this group are indicated for neck cannula insertion due to tzpu of cardiac surgery (MICS) |
| Central venous catheter only group | – | –Patients in this group are indicated for central venous catheter insertion only. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- adult patients undergoing cardiac surgery
Key exclusion criteria (1 listed)
- Any pathology of right internal jugular vein on preoperative ultrasound (vein not fully compressible, hypoplastic jugular vein, preoperative invasion on right jugular vein)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neck cannula insertionNeck cannula insertion is necessary for establishing of cardiopulmonary bypass for Minimally Invasive Cardiac Surgery. It is routine procedure for this type of cardiac surgery. | Procedure or surgery | Neck cannula group |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2019.
- Background: PubMed 22361820Vernick 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.
- Background: PubMed 25575244Brass 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zdenek Turek, MD, Ph.D. principal investigator
University Hospital Hradec Kralove, Dept. of Anesthesiology, Sokolska 581, Hradec Kralove, 50005, Czech Republic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Surgical Procedure, run by University Hospital Hradec Kralove at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative patency of internal jugular vein (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02456259, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2019.