Subcutaneous Nitroglycerin to Prevent Radial Artery Occlusion in Children

Effect of Subcutaneous Nitroglycerin on the Prevention of Radial Artery Occlusion After Radial Artery Catheterization in Pediatric Patients - a Prospective Randomized Controlled Trial

The primary objective of the study is to evaluate the vasodilative effect of subcutaneous nitroglycerin to prevent radial arterial occlusion(RAO) after removal of the radial arterial catheter in pediatric patients. The hypothesis of this study is that subcutaneous nitroglycerin will decrease the incidence of radial arterial occlusion after radial arterial catheter removal in pediatric patients by increasing the radial artery size. This is a single-center, double-blind, randomized, placebo-controlled study comparing the effect of subcutaneous nitroglycerin and saline on radial artery cannulation and catheter removal in pediatric patients. Prior to the procedure, each patient will be randomized into either the control arm, saline, or the study arm, nitroglycerin.

Study Overview

• Status: Completed
• Conditions: Ischemia; Arterial Line
• Intervention / Treatment: Drug: Nitroglycerin; Drug: Normal saline

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 3 years (Child)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients undergoing General anesthesia
• Patients in the Intensive care unit
• Arterial cannulation for hemodynamic monitoring, or multiple blood sample

Exclusion Criteria:

• Unstable vital signs, significant arrhythmia or hypotension, Shock
• High risk of peripheral ischemia
• Skin disease, infection, hematoma, recent cannulation at the radial artery
• History of anaphylaxis to nitroglycerin

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nitroglycerin; Nitroglycerin 5mcg/kg (in 0.5cc) is subcutaneously injected before radial artery cannulation and before removal of the radial arterial catheter.	Drug: Nitroglycerin; Subcutaneous nitroglycerin injection to decrease the incidence of radial arterial occlusion after arterial catheter removal in pediatric patients.
Active Comparator: Control; Normal saline (0.5cc) is subcutaneously injected before radial artery cannulation and before removal of the radial arterial catheter.	Drug: Normal saline; Subcutaneous normal saline injection to decrease the incidence of radial arterial occlusion after arterial catheter removal in pediatric patients.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The incidence of radial arterial occlusion (RAO) (%)	RAO is defined as no pulse oximeter wave at the index finger during compression of the ipsilateral ulnar artery.	After removal of the radial artery catheter (up to 24 hour)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
First attempt success rate (%)	Success at the first skin puncture	During radial artery cannulation (up to 1 hour)
Size of radial artery (mm)	Internal diameter of radial artery	Before and after subcutaneous injection of drugs / Before and after catheterization / Before and after removal of the catheter (up to 1 hour)
depth of radial artery (mm)	depth of radial artery from the skin	Before and after subcutaneous injection of drugs / Before and after catheterization / Before and after removal of the catheter (up to 1 hour)
flow velocity of the radial artery (cm/s)	flow velocity of the radial artery measured by Doppler ultrasound	Before and after subcutaneous injection of drugs / Before and after catheterization / Before and after removal of the catheter (up to 1 hour)
Perfusion index	Perfusion index measured by pulse oximeter sensor at the distally located index finger of radial arterial catheterization	Before and after subcutaneous injection of drugs / Before and after catheterization / Before and after removal of the catheter (up to 1 hour)
Overall attempt (number)	Number of attempt of radial artery cannulation	During radial artery cannulation (up to 1 hour)
Overall Procedure time (seconds)	From ultrasound guidance, to Arterial waveform	During radial artery cannulation (up to 1 hour)
Overall success rate (%)	Success within 2 skin puncture and within 10 minutes	During radial artery cannulation (up to 1 hour)
Incidence of posterior wall puncture (%)	Incidence of posterior wall (transfixation technique) puncture during radial arterial catherization	During radial artery cannulation (up to 1 hour)
Number of arteries cannulated	Number of arteries cannulated for peripheral arterial catheterization	During radial artery cannulation (up to 1 hour)
Malfunction of radial artery catheter	Invasive blood pressure monitoring, Sampling (%)	After radial artery cannulation assessed during anesthesia (per 24hour, up to 480 hour)
Complication rate	Hematoma, Distal ischemia, Spasm accessed by ultrasound (%)	After radial artery cannulation assessed up to PACU, PICU stay (per 24hour, up to 480 hour)
Duration of radial arterial catherization	Duration of radial arterial catherization (hours, minutes)	After radial artery cannulation assessed during anesthesia (up to 480 hour)

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Investigators: Principal Investigator: Young-Eun Jang, MD, PhD, Clinical assistant professor, Department of anesthesiology and pain medicine

Publications and helpful links

General Publications

• Kim EH, Lee JH, Song IK, Kim JT, Lee WJ, Kim HS. Posterior Tibial Artery as an Alternative to the Radial Artery for Arterial Cannulation Site in Small Children: A Randomized Controlled Study. Anesthesiology. 2017 Sep;127(3):423-431. doi: 10.1097/ALN.0000000000001774.
• Jang YE, Cho SA, Ji SH, Kim EH, Lee JH, Kim HS, Kim JT. Smart Glasses for Radial Arterial Catheterization in Pediatric Patients: A Randomized Clinical Trial. Anesthesiology. 2021 Oct 1;135(4):612-620. doi: 10.1097/ALN.0000000000003914.
• Jang YE, Ji SH, Kim EH, Lee JH, Kim HS, Mossad EB, Kim JT. Subcutaneous Nitroglycerin for Radial Arterial Catheterization in Pediatric Patients: A Randomized Controlled Trial. Anesthesiology. 2020 Jul;133(1):53-63. doi: 10.1097/ALN.0000000000003308.
• Jang YE, Kim EH, Lee JH, Kim HS, Kim JT. Guidewire-assisted vs. direct radial arterial cannulation in neonates and infants: A randomised controlled trial. Eur J Anaesthesiol. 2019 Oct;36(10):738-744. doi: 10.1097/EJA.0000000000001064.

Study record dates

Study Major Dates

• Study Start (Actual): September 8, 2022
• Primary Completion (Actual): March 24, 2025
• Study Completion (Actual): March 24, 2025

Study Registration Dates

• First Submitted: June 29, 2022
• First Submitted That Met QC Criteria: June 29, 2022
• First Posted (Actual): July 5, 2022

Study Record Updates

• Last Update Posted (Actual): April 29, 2025
• Last Update Submitted That Met QC Criteria: April 24, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Radial Artery; Vascular Catheters
• Additional Relevant MeSH Terms: Pathologic Processes; Ischemia; Vasodilator Agents; Nitroglycerin
• Other Study ID Numbers: H-2206-070-1332

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No