Subcutaneous Nitroglycerin to Prevent Radial Artery Occlusion in Children

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 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.

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

Conditions
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Arterial Line, Ischemia

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: 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

Ages Eligible for Study
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Maximum Age: 36 Months

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nitroglycerin<br>Nitroglycerin 5mcg/kg (in 0.5cc) is subcutaneously injected before radial artery cannulation and before removal of the radial arterial catheter. | Drug: Nitroglycerin<br>* Subcutaneous nitroglycerin injection to decrease the incidence of radial arterial occlusion after arterial catheter removal in pediatric patients.<br>|
| Active Comparator: Control<br>Normal saline (0.5cc) is subcutaneously injected before radial artery cannulation and before removal of the radial arterial catheter. | Drug: Normal saline<br>* Subcutaneous normal saline injection to decrease the incidence of radial arterial occlusion after arterial catheter removal in pediatric patients.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 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) | 
| Size of radial artery (mm) | Internal diameter of radial artery | 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) | depth of radial artery from the skin | 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) | flow velocity of the radial artery measured by Doppler ultrasound | Before and after subcutaneous injection of drugs / Before and after catheterization / Before and after removal of the catheter (up to 1 hour) | 
| Perfusion index | Perfusion index measured by pulse oximeter sensor at the distally located index finger of radial arterial catheterization | Before and after subcutaneous injection of drugs / Before and after catheterization / Before and after removal of the catheter (up to 1 hour) | 
| Overall attempt (number) | Number of attempt of radial artery cannulation | During radial artery cannulation (up to 1 hour) | 
| Overall Procedure time (seconds) | From ultrasound guidance, to Arterial waveform | During radial artery cannulation (up to 1 hour) | 
| Overall success rate (%) | Success within 2 skin puncture and within 10 minutes | During radial artery cannulation (up to 1 hour) | 
| Incidence of posterior wall puncture (%) | Incidence of posterior wall (transfixation technique) puncture during radial arterial catherization | During radial artery cannulation (up to 1 hour) | 
| Number of arteries cannulated | Number of arteries cannulated for peripheral arterial catheterization | 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 (per 24hour, up to 480 hour) | 
| Complication rate | Hematoma, Distal ischemia, Spasm accessed by ultrasound (%) | After radial artery cannulation assessed up to PACU, PICU stay (per 24hour, up to 480 hour) | 
| Use of vasoactive drugs | The vasoactive drugs used between cannulation and removal of the radial arterial catheter (yes/no) | After radial artery cannulation assessed during anesthesia (per 24hour, up to 480 hour) | 
| Duration of radial arterial catherization | Duration of radial arterial catherization (hours, minutes) | After radial artery cannulation assessed during anesthesia (up to 480 hour) | 

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