- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04432844
Ultrasound Guided Internal Jugular Vein Cannulation Using Biplanar Imaging: A Pilot Study
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
New Territories
-
Shatin, New Territories, Hong Kong
- Prince of Wales Hosptial
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- American Society of Anesthesiologists (ASA) physical status I to III
- Patients posted for elective cardiac surgeries under general anaesthesia.
Exclusion Criteria:
- Patient refusal
- skin entry site infection
- history of previous IJV cannulation
- obese patients (BMI>30)
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Procedure (before surgery after general anesthesia)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
number of skin puncture
Time Frame: from the start of IJV insertion till the end of the procedure
|
the number of skin puncture for the procedure
|
from the start of IJV insertion till the end of the procedure
|
number of needle re-directions
Time Frame: Procedure during IJV insertion
|
changes in the direction of needle insertion without removing it from the skin
|
Procedure during IJV insertion
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IJV Protocol V2
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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