Clinical trial

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

Name
H-2206-070-1332
Description
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.
Trial arms
Trial start
2022-09-08
Estimated PCD
2025-06-01
Trial end
2025-07-01
Status
Recruiting
Treatment
Nitroglycerin
Subcutaneous nitroglycerin injection to decrease the incidence of radial arterial occlusion after arterial catheter removal in pediatric patients.
Arms:
Nitroglycerin
Normal saline
Subcutaneous normal saline injection to decrease the incidence of radial arterial occlusion after arterial catheter removal in pediatric patients.
Arms:
Control
Size
200
Primary endpoint
The incidence of radial arterial occlusion (RAO) (%)
After removal of the radial artery catheter (up to 24 hour)
Eligibility criteria
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 200, 'type': 'ESTIMATED'}}
Updated at
2023-11-24

1 organization

2 products

2 indications

Indication
Arterial Line
Indication
Ischemia