Cardiac DiseaseNCT04432844
Ultrasound Guided Internal Jugular Vein Cannulation Using Biplanar Imaging: A Pilot Study
An observational study of Cardiac Disease, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
Central Venous access by real-time ultrasound guidance is considered as gold standard and a recommended clinical practice. Internal jugular vein cannulation is one of the central venous access commonly used for major cardiac surgeries for monitoring and administering life-saving medications. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cardiac Disease
- What is being tested?
- Biplanar Ultrasound guided Internal Jugular Vein Cannulation
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- 1 siteHong Kong
- Study dates
- 2 Jul 2020to 30 Nov 2020
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients scheduled for elective cardiac surgeries that meet the inclusion criteria will be recruited.
Who may be able to join
- American Society of Anesthesiologists (ASA) physical status I to III
- Patients posted for elective cardiac surgeries under general anaesthesia.
Who cannot join
- Patient refusal
- skin entry site infection
- history of previous IJV cannulation
- obese patients (BMI>30)
Trial locations and contacts
1 site in 1 country.
About this study
Central Venous access by real-time ultrasound guidance is considered as gold standard and a recommended clinical practice. Internal jugular vein cannulation is one of the central venous access commonly used for major cardiac surgeries for monitoring and administering life-saving medications. In daily practice internal jugular vein cannulation is done under the guidance of ultrasound imaging after general anesthesia before the surgery. Real time 2D ultrasound guidance (USG) during central venous cannulation (CVC) has shown to be superior to the traditional anatomical landmark guided CVC, but the incidence of carotid puncture is still 4.2%. Any improvement that aids in the ease and safety of the procedures needs to be evaluated. Recently USG biplanar imaging can now successfully demonstrate real time imaging in two different views at the same time. Theoretically, this may help improve precision by improving real time needle tip visualization and thereby reduce potential complications as compared to a traditional 2D approach. This study aims to assess the feasibility of biplanar USG internal jugular venous cannulation.
Read the detailed description
This is a single arm prospective observational pilot study conducted at Prince of Wales Hospital in Hong Kong SAR. 20 adult patients scheduled for elective cardiac surgeries under general anesthesia (GA) will be recruited. After GA, patients will be positioned in the head low position for the USG guided IJV access. The skin of the neck will be prepared in a standard aseptic fashion. After sterilization, the surrounding area will be covered with a full-body sterile drape. The footprint and the cable of the ultrasound transducer will also be covered with a sterile transparent cover. Sterile ultrasound gel will be used for acoustic coupling during the USG guided CVC placement, but care will be taken to avoid inserting the needle through the US gel.
USG XL 14-3 transducer will be used to obtain the biplanar imaging of IJV. A 3 lumen CVC will be used to access the IJV. An experienced anesthesiologist shall perform the USG guided procedure using the Seldinger method. This special transducer can provide real-time short axis (out of the plane) and long axis (In-plane) view which can be used to identify, locate and choose the introducer needle entry site for IJV vascular access. IJV will be assessed for any anatomical variations, pre-existing pathologies and patency. Among the 'out of plane' and 'in plane' view, the former will be used as a primary view to guide the CVC introducer needle. The reference mark/line in the primary 'out of the plane' image in the biplanar view can be adjusted sidewise to visualise the needle in the 'in plane' view. As the needle is visualised in the 'in plane' technique (figure 1), the relative position of the needle to the target IJV can be determined which will further help in redirecting the needle towards the IJV. Needle tip can be made visualised in the 'out of the plane' view by carefully moving the transducer initially towards the introducer needle. Once the needle tip is visualised, it is advanced further towards the target taking into consideration both the 'in plane' and 'out of plane' image guidance. When the needle is visualised (in both the views) inside the vein, the transducer will be kept aside, a 5 ml syringe will be used to aspirate blood and then the guidewire is inserted into the IJV. Presence of guidewire will be again confirmed using the same biplanar transducer before performing the dilatation of IJV and final passage of the CVC. Likewise, the final position of the CVC shall also be confirmed using biplanar imaging. After final confirmation, CVC will be secured safely to the neck using sutures and connected to the pressure transducers for central venous pressure (CVP) monitoring.
- Conditions
- Cardiac Disease
- Being tested
- Biplanar Ultrasound guided Internal Jugular Vein Cannulation
- Medical subject headings
- Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biplanar Ultrasound guided Internal Jugular Vein CannulationProcedure or surgery
Using Philips EPIQ elite ultrasound system with a high-frequency 3D and 4D volume linear array transducer (USG XL 14-3) to obtain the biplanar imaging of Internal jugular vein cannulation.
What is being measured
The primary outcome is the main question the study is designed to answer.
Time taken for successful IJV cannulation
The time taken from the skin puncture to the aspiration of blood
Measured: Procedure (before surgery after general anesthesia)
Secondary outcomes (2)
number of skin puncture
the number of skin puncture for the procedure
Measured: from the start of IJV insertion till the end of the procedure
number of needle re-directions
changes in the direction of needle insertion without removing it from the skin
Measured: Procedure during IJV insertion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2020
- Study start2 Jul 2020
- Primary completion30 Nov 2020
- Study completion30 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac DiseaseStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- 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 only
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof Manoj K Karmakar, Chinese University of Hong Kong
- Investigators
- Manoj K Karmakar, MD, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04432844
- Sponsor's protocol ID
- IJV Protocol V2
- Status last verified
- Jan 2021
- First submitted
- 12 Jun 2020
- Last updated
- 27 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Guided Internal Jugular Vein Cannulation Using Biplanar Imaging: A Pilot Study
- ClinicalTrials.gov ID
- NCT04432844
- Acronym / sponsor ID
- IJV Protocol V2
- Conditions
- Cardiac Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 2 Jul 2020 (actual)
- Primary completion
- 30 Nov 2020 (actual)
- Study completion
- 30 Nov 2020 (actual)
- First posted
- 16 Jun 2020 (actual)
- 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.
Central Venous access by real-time ultrasound guidance is considered as gold standard and a recommended clinical practice. Internal jugular vein cannulation is one of the central venous access commonly used for major cardiac surgeries for monitoring and administering life-saving medications. In daily practice internal jugular vein cannulation is done under the guidance of ultrasound imaging after general anesthesia before the surgery. Real time 2D ultrasound guidance (USG) during central venous cannulation (CVC) has shown to be superior to the traditional anatomical landmark guided CVC, but the incidence of carotid puncture is still 4.2%. Any improvement that aids in the ease and safety of the procedures needs to be evaluated. Recently USG biplanar imaging can now successfully demonstrate real time imaging in two different views at the same time. Theoretically, this may help improve precision by improving real time needle tip visualization and thereby reduce potential complications as compared to a traditional 2D approach. This study aims to assess the feasibility of biplanar USG internal jugular venous cannulation.
Detailed description
This is a single arm prospective observational pilot study conducted at Prince of Wales Hospital in Hong Kong SAR. 20 adult patients scheduled for elective cardiac surgeries under general anesthesia (GA) will be recruited. After GA, patients will be positioned in the head low position for the USG guided IJV access. The skin of the neck will be prepared in a standard aseptic fashion. After sterilization, the surrounding area will be covered with a full-body sterile drape. The footprint and the cable of the ultrasound transducer will also be covered with a sterile transparent cover. Sterile ultrasound gel will be used for acoustic coupling during the USG guided CVC placement, but care will be taken to avoid inserting the needle through the US gel.
USG XL 14-3 transducer will be used to obtain the biplanar imaging of IJV. A 3 lumen CVC will be used to access the IJV. An experienced anesthesiologist shall perform the USG guided procedure using the Seldinger method. This special transducer can provide real-time short axis (out of the plane) and long axis (In-plane) view which can be used to identify, locate and choose the introducer needle entry site for IJV vascular access. IJV will be assessed for any anatomical variations, pre-existing pathologies and patency. Among the 'out of plane' and 'in plane' view, the former will be used as a primary view to guide the CVC introducer needle. The reference mark/line in the primary 'out of the plane' image in the biplanar view can be adjusted sidewise to visualise the needle in the 'in plane' view. As the needle is visualised in the 'in plane' technique (figure 1), the relative position of the needle to the target IJV can be determined which will further help in redirecting the needle towards the IJV. Needle tip can be made visualised in the 'out of the plane' view by carefully moving the transducer initially towards the introducer needle. Once the needle tip is visualised, it is advanced further towards the target taking into consideration both the 'in plane' and 'out of plane' image guidance. When the needle is visualised (in both the views) inside the vein, the transducer will be kept aside, a 5 ml syringe will be used to aspirate blood and then the guidewire is inserted into the IJV. Presence of guidewire will be again confirmed using the same biplanar transducer before performing the dilatation of IJV and final passage of the CVC. Likewise, the final position of the CVC shall also be confirmed using biplanar imaging. After final confirmation, CVC will be secured safely to the neck using sutures and connected to the pressure transducers for central venous pressure (CVP) monitoring.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients scheduled for elective cardiac surgeries that meet the inclusion criteria will be recruited.
Key inclusion criteria (2 listed)
- American Society of Anesthesiologists (ASA) physical status I to III
- Patients posted for elective cardiac surgeries under general anaesthesia.
Key exclusion criteria (4 listed)
- Patient refusal
- skin entry site infection
- history of previous IJV cannulation
- obese patients (BMI>30)
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 |
|---|---|---|
| Biplanar Ultrasound guided Internal Jugular Vein CannulationUsing Philips EPIQ elite ultrasound system with a high-frequency 3D and 4D volume linear array transducer (USG XL 14-3) to obtain the biplanar imaging of Internal jugular vein cannulation. | Procedure or surgery | – |
Primary outcome
Time taken for successful IJV cannulation
Time frame: Procedure (before surgery after general anesthesia)
The time taken from the skin puncture to the aspiration of blood
2 secondary outcomes
number of skin puncture
Time frame: from the start of IJV insertion till the end of the procedure
number of needle re-directions
Time frame: Procedure during IJV insertion
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 27 Jan 2021.
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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.
Manoj K Karmakar, MD principal investigator
Chinese University of Hong Kong
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 Disease, run by Chinese University of Hong Kong at 1 site in Hong Kong.
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 2 inclusion and 4 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 27 Jan 2021. 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 Hong Kong. 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?
Time taken for successful IJV cannulation (time frame: Procedure (before surgery after general anesthesia)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Jan 2021.