NCT04432844

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2020

Shorter than P25 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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 12, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 16, 2020

Completed
16 days until next milestone

Study Start

First participant enrolled

July 2, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2020

Completed
Last Updated

January 27, 2021

Status Verified

January 1, 2021

Enrollment Period

5 months

First QC Date

June 12, 2020

Last Update Submit

January 26, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Time taken for successful IJV cannulation

    The time taken from the skin puncture to the aspiration of blood

    Procedure (before surgery after general anesthesia)

Secondary Outcomes (2)

  • number of skin puncture

    from the start of IJV insertion till the end of the procedure

  • number of needle re-directions

    Procedure during IJV insertion

Interventions

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.

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients scheduled for elective cardiac surgeries that meet the inclusion criteria will be recruited.

You may qualify if:

  • American Society of Anesthesiologists (ASA) physical status I to III
  • Patients posted for elective cardiac surgeries under general anaesthesia.

You may not qualify if:

  • Patient refusal
  • skin entry site infection
  • history of previous IJV cannulation
  • obese patients (BMI\>30)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prince of Wales Hosptial

Shatin, New Territories, Hong Kong

Location

MeSH Terms

Conditions

Heart Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Study Officials

  • Manoj K Karmakar, MD

    Chinese University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 12, 2020

First Posted

June 16, 2020

Study Start

July 2, 2020

Primary Completion

November 30, 2020

Study Completion

November 30, 2020

Last Updated

January 27, 2021

Record last verified: 2021-01

Locations