NCT03405623

Brief Summary

When performing vascular cannulation such as radial artery cannulation, ultrasonography (US) helps proper positioning of the tip of needle in the vascular lumen, which facilitating cannulation of the catheter and successful pressure monitoring. Conventionally, short-axis out-of-plane (SAX) and long-axis in-plane (LAX) views are commonly used method to image the target vessel during cannulation under US guidance. Dynamic needle tip positioning (DNTP) method is newly introduced by one group of investigators who conducted a related study using vascular phantom model. In DNTP, SAX is used, and additionally, when the needle tip is imaged in the screen as an echogenic point, the practitioner (a) proximally moves the US probe a bit, and then (b) the needle is advanced until the needle tip reappears in the screen. In this manner, the practitioner repeats (a) and (b) until the needle is inserted 1 cm into the lumen of vessel, and then the catheter is inserted to finish the procedure. DNTP has not been compared to conventional imaging methods. The aim of this trial is to see the effect of DNTP on success rate of the radial artery cannulation at the first attempt, compared to the conventional LAX.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
146

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2018

Shorter than P25 for not_applicable

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

January 15, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 23, 2018

Completed
7 days until next milestone

Study Start

First participant enrolled

January 30, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 4, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 4, 2018

Completed
Last Updated

September 20, 2018

Status Verified

September 1, 2018

Enrollment Period

4 months

First QC Date

January 15, 2018

Last Update Submit

September 19, 2018

Conditions

Cardiac Surgical ProceduresCatheterizationUltrasonography

Outcome Measures

Primary Outcomes (1)

  • Success rate of the radial artery cannulation at first attempt

    Successful confirmation of the arterial waveform through a pressure monitor at first attempt of the radial artery cannulation

    intraoperative

Secondary Outcomes (1)

  • Time between skin puncture to confirmation of the arterial waveform through a pressure monitoring device.

    During the cannulation procedure.

Study Arms (2)

Dynamic needle tip positioning

ACTIVE COMPARATOR

In DNTP, SAX is used, and additionally, when the needle tip is imaged in the screen as an hyper-echoic point, the practitioner (a) moves the US probe proximally a bit, and (b) the needle is advanced until the needle tip reappears in the screen. In this manner, the practitioner repeats (a) and (b) until the needle is inserted 1 cm into the lumen of vessel, and then the catheter is inserted to finish the procedure.

Procedure: Dynamic needle tip positioning under ultrasound-guidance

Conventional long-axis

ACTIVE COMPARATOR
Procedure: Conventional long-axis view

Interventions

Dynamic needle tip positioning under ultrasound-guidancePROCEDURE

The tip of needle is positioned under ultrasound-guidance using dynamic short-axis view.

Dynamic needle tip positioning
Conventional long-axis viewPROCEDURE

The tip of needle is positioned under ultrasound-guidance using conventional long-axis in-plane view.

Conventional long-axis

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Elective cardiovascular surgery where RA catheterization is newly required.

You may not qualify if:

  • skin infection or trauma
  • Bilateral arteriovenous fistula for dialysis
  • Severe peripheral vascular disease
  • Severe arteriosclerosis or arterial atheroma
  • Raynaud disease
  • Shock
  • Patients on ECMO or IABP support
  • Morbid obesity
  • Profound coagulopathy
  • Negative results of modified Allen's test

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Related Publications (1)

  • Flumignan RL, Trevisani VF, Lopes RD, Baptista-Silva JC, Flumignan CD, Nakano LC. Ultrasound guidance for arterial (other than femoral) catheterisation in adults. Cochrane Database Syst Rev. 2021 Oct 12;10(10):CD013585. doi: 10.1002/14651858.CD013585.pub2.

    PMID: 34637140DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Assistant Professor

Study Record Dates

First Submitted

January 15, 2018

First Posted

January 23, 2018

Study Start

January 30, 2018

Primary Completion

June 4, 2018

Study Completion

June 4, 2018

Last Updated

September 20, 2018

Record last verified: 2018-09

Locations

KR(1)