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NCT02795468 Clinical Trial

The Usefulness of Ultrasound Guided Technique Insertion of Radial Artery Catheter in Neonates and Infants

Catheterization, Peripheral Clinical Trial

Official title:
The Usefulness of Ultrasound Guided Technique Insertion of Radial Artery Catheter in Neonates and Infants

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02795468
Other study ID # 2016-03-128-001
Secondary ID
Status Completed
Phase N/A
First received May 26, 2016
Last updated April 24, 2018
Start date June 2016
Est. completion date February 28, 2017

Study information
Verified date April 2018
Source Samsung Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The investigators are trying to compare the ultrasound-guided technique vs. palpation method for radial arterial cannulation in infants.

Description:

In infants (<12mo), radial arterial catheterization is sometimes difficult to perform. Moreover, repeated attempts itself would cause the arterial spasm or hematoma. The use of ultrasound as an adjunct to radial arterial cannulation has considered to be the best practice in adults and pediatrics. However, its usefulness or superiority for neonates and infants is not known. Therefore, we would compare ultrasound guided radial arterial cannulation with the usual palpation methods in infants undergoing cardiac surgery.

Recruitment information / eligibility
Status Completed
Enrollment 86
Est. completion date February 28, 2017
Est. primary completion date February 2017
Accepts healthy volunteers No
Gender All
Age group N/A to 12 Months
Eligibility Inclusion Criteria:

- Infants under 12 months age undergoing cardiac surgery with radial arterial cannulation

Exclusion Criteria:

- Sign of a skin infection

- Wound near the puncture site

- abnormal circulation of the hand

- any vascular problem at radial or ulnar artery

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Radial arterial cannulation
Radial arterial cannulation using usual palpation method or ultrasound guided technique according to the group

Locations
Country Name City State
Korea, Republic of Samsung Medical Center Seoul

Sponsors (1)
Lead Sponsor Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary First-pass success rate Within 10 min from the start time of arterial cannulation using an angiocath
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