Subcutaneous Nitroglycerin to Prevent Radial Artery Occlusion in Children

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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

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

Trial contacts and locations

1

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Central trial contact

Young-Eun Jang, MD, PhD

Data sourced from clinicaltrials.gov

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