Subcutaneous Nitroglycerin to Prevent Radial Artery Occlusion in Children

NCT05443061 | Completed

• 1 other identifier: H-2206-070-1332
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Arterial Line; Ischemia

Keywords

Radial Artery; Vascular Catheters

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (13)

• First attempt success rate (%)

  During radial artery cannulation (up to 1 hour)

• Size of radial artery (mm)

  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)

  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)

  Before and after subcutaneous injection of drugs / Before and after catheterization / Before and after removal of the catheter (up to 1 hour)

• Perfusion index

  Before and after subcutaneous injection of drugs / Before and after catheterization / Before and after removal of the catheter (up to 1 hour)

Study Arms (2)

Nitroglycerin

EXPERIMENTAL

Nitroglycerin 5mcg/kg (in 0.5cc) is subcutaneously injected before radial artery cannulation and before removal of the radial arterial catheter.

Drug: Nitroglycerin

Control

ACTIVE COMPARATOR

Normal saline (0.5cc) is subcutaneously injected before radial artery cannulation and before removal of the radial arterial catheter.

Drug: Normal saline

Interventions

Nitroglycerin DRUG

Subcutaneous nitroglycerin injection to decrease the incidence of radial arterial occlusion after arterial catheter removal in pediatric patients.

Nitroglycerin

Normal saline DRUG

Subcutaneous normal saline injection to decrease the incidence of radial arterial occlusion after arterial catheter removal in pediatric patients.

Control

Eligibility Criteria

• Age: Up to 36 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

Related Publications (5)

• 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.

  PMID: 32282432 BACKGROUND

• 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.

  PMID: 34352073 BACKGROUND

• 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.

  PMID: 31356376 BACKGROUND

• 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.

  PMID: 28682811 BACKGROUND

• Park JB, Ji SH, Kim EH, Lee JH, Kim HS, Kim JT, Jang YE. Subcutaneous Nitroglycerin to Prevent Radial Artery Occlusion in Pediatric Patients: A Randomized Clinical Trial. JAMA Pediatr. 2025 Dec 1;179(12):1283-1290. doi: 10.1001/jamapediatrics.2025.3652.

  PMID: 41051743 DERIVED

MeSH Terms

Conditions

Ischemia

Interventions

Nitroglycerin; Saline Solution

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nitro Compounds; Organic Chemicals; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Young-Eun Jang, MD, PhD

  Clinical assistant professor, Department of anesthesiology and pain medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical assistant professor

Study Record Dates

• First Submitted: June 29, 2022
• First Posted: July 5, 2022
• Study Start: September 8, 2022
• Primary Completion: March 24, 2025
• Study Completion: March 24, 2025
• Last Updated: April 29, 2025

Record last verified: 2025-04

Locations

KR (1)