Subcutaneous Nitroglycerin to Prevent Radial Artery Occlusion in Children

Seoul National University

Status: Enrolling

Conditions: Arterial Line; Ischemia

Treatments: Drug: Normal saline; Drug: Nitroglycerin

Study type: Interventional

Funder types: Other

Identifiers

NCT05443061

H-2206-070-1332

Details and patient eligibility

About

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 and improving the first-attempt success rate of radial artery cannulation. 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.

Enrollment: 200 estimated patients

Sex: All

Ages: Under 36 months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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200 participants in 2 patient groups

Nitroglycerin

Experimental group

Description:

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

Treatment:

Drug: Nitroglycerin

Control

Active Comparator group

Description:

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

Treatment:

Drug: Normal saline