Guidewire-assisted Radial A-line in Neonate and Infant

Arterial Line Clinical Trial

Official title:

Comparison of Radial Artery Cannulation Technique in Pediatric Patients: Direct Versus Guidewire-assisted

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03217019
• Other study ID #: 1706-086-859
• Status: Completed
• Phase: N/A
• Start date: August 7, 2017
• Est. completion date: July 4, 2018

Study information

• Verified date: April 2019
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In neonate and infant, radial artery cannulation may be challenging and multiple attempts are required because of the small diameter.

The invastigators will compare the success rates of radial arterial cannulation with a guidewire-assisted technique and the direct technique in pediatric patient(<1yr).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: July 4, 2018
• Est. primary completion date: July 4, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 1 Year

Eligibility

Inclusion Criteria:

• Pediatric patients undergoing general anesthesia with arterial cannulation (for hemodynamic monitoring or blood sampling)

Exclusion Criteria:

• Skin lesion, infection, hematoma, recent cannulation at cannulation site

• Unstable radial pulse (d/t unstable vital sign, or arrhythmias)

Related Conditions & MeSH terms

• Arterial Line

Intervention

Procedure:
• Guidewire-assist
catheter insertion with guidewire-assist(catheter over guidewire)
• Direct
catheter insertion without guidewire assist(catheter over needle)

Locations

Country	Name	City	State
Korea, Republic of	Jin-Tae Kim	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 at 1st attempt (%)	successful catheter insertion after obtaining 1st blood flush in angiocatheter.	from arterial cannulation to successful invasive BP monitoring (up to 1 hour)
Secondary	total elapsed time (seconds)	total time for successful cannulation.	from arterial cannulation to successful invasive BP monitoring (up to 1 hour)
Secondary	number of total cannulation attempts (number)	number of total attempts until successful cannulation. (1 attempt = 1 blood flush)	from arterial cannulation to successful invasive BP monitoring (up to 1 hour)
Secondary	number of total catheter used (number)	number of total catheter used until successful cannulation.	from arterial cannulation to successful invasive BP monitoring (up to 1 hour)
Secondary	malfunction of arterial line	pressure monitoring, blood sampling	from the start of invasive BP monitoring until the end of anesthesia (up to 1 day)
Secondary	complications	hematoma, ischemia	from the arterial cannulation until the end of anesthesia (up to 1 day)