Subcutaneous Nitroglycerin for Pediatric Radial Artery Cannulation

Study Overview
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Brief Summary
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The primary objective of the study is to evaluate the vasodilative effect of subcutaneous nitroglycerin during ultrasound-guided radial artery cannulation in pediatric patients. The hypothesis of this study is that the subcutaneous nitroglycerin will increase the radial artery size and improve 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 in pediatric patients undergoing general anesthesia. Prior to the procedure, each patient will be randomized into either the control arm, saline, or study arm, nitroglycerin.

Official Title
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The Effect of Subcutaneous Nitroglycerin on the Success Rate of Arterial Catheterization in Pediatric Patients: a Randomized Controlled Trial

Conditions
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Arterial Line

Intervention / Treatment
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* Drug: Nitroglycerin
* Drug: Normal saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: General anesthesia Arterial cannulation for hemodynamic monitoring, multiple blood sample Exclusion Criteria: Hypersensitivity or contraindication to nitroglycerine Unstable vital sign, significant arrhythmia or hypotension, Shock High risk of peripheral ischemia Skin disease, infection, hematoma, recent cannulation at radial artery. Increased intracranial pressure, Intracranial hemorrhage Glaucoma Recent use of PDE5 inhibitors (<24 hours after sildenafil or vardenafil; <48 hours after tadalafil)

Ages Eligible for Study
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Maximum Age: 2 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nitroglycerin<br>Nitroglycerin 5mcg/kg (0.5cc) is subcutaneously injected before radial artery cannulation. | Drug: Nitroglycerin<br>* Subcutaneous nitroglycerin injection to increase the first attempt success rate of radial artery cannulation in pediatric patients<br>* Other names: Subcutaneous Nitroglycerin;|
| Active Comparator: Control<br>Normal saline (0.5cc) is subcutaneously injected before radial artery cannulation. | Drug: Normal saline<br>* Subcutaneous normal saline injection to increase the first attempt success rate of radial artery cannulation in pediatric patients<br>* Other names: Subcutaneous Normal saline;|

What is the study measuring?
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Primary 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) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Size of radial artery | Internal diameter of radial artery | Before and after subcutaneous injection of drugs (up to 1 hour) | 
| depth of radial artery | depth of radial artery from the skin | Before and after subcutaneous injection of drugs (up to 1 hour) | 
| Overall attempt | Number of attempt of radial artery cannulation | During radial artery cannulation (up to 1 hour) | 
| Overall Procedure time | From ultrasound guidance, to Arterial waveform | During radial artery cannulation (up to 1 hour) | 
| Overall success rate | Success within 4 skin puncture (2 skin puncture at each radial artery) | 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 (up to 24 hour) | 
| Complication rate | Hematoma, Distal ischemia, Spasm accessed by ultrasound | After radial artery cannulation assessed up to PACU, PICU stay (per 24hour, up to 48 hour) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Radial Artery, Vascular Catheters