Dynamic SAX vs Conventional LAX in Radial Artery Cannulation.

Ultrasonography Clinical Trial

Official title:

Randomized Trial of Ultrasound-guided Radial Artery Cannulation Using Dynamic Short Axis Versus Conventional Long-axis In-plane View in Cardiac Surgery Patients.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03405623
• Other study ID #: DNTP vs LAX
• Status: Completed
• Phase: N/A
• Start date: January 30, 2018
• Est. completion date: June 4, 2018

Study information

• Verified date: September 2018
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 146
• Est. completion date: June 4, 2018
• Est. primary completion date: June 4, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

• Elective cardiovascular surgery where RA catheterization is newly required.

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Cardiac Surgical Procedures
• Catheterization
• Ultrasonography

Intervention

Procedure:
• Dynamic needle tip positioning under ultrasound-guidance
The tip of needle is positioned under ultrasound-guidance using dynamic short-axis view.
• Conventional long-axis view
The tip of needle is positioned under ultrasound-guidance using conventional long-axis in-plane view.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Time between skin puncture to confirmation of the arterial waveform through a pressure monitoring device.		During the cannulation procedure.