Ultrasound Guided Peripheral Intravenous Catheterization in the Pediatric Intensive Care Unit.

Study Overview
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Brief Summary
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This is a randomized controlled prospective study. The purpose of this study is to compare a recently described technique of ultrasound (US) guided, dynamic needle tip positioning (DNTP), to the traditional technique of vein visualization and palpation for peripheral venous cannulation in intubated, sedated, and mechanically ventilated pediatric intensive care unit (PICU) patients. First attempt success rate, overall success rate within 3 attempts or 10 minutes (whichever comes first), number of attempts to success, time to success and cannula sizes will be compared between the 2 techniques. The study will include intubated, sedated and mechanically ventilated children, aged 0-18 years, hospitalized in the PICU who require peripheral intravenous (PIV) access for their management.

Official Title
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Ultrasound Guided Peripheral Intravenous Catheterization in Children Hospitalized in the Pediatric Intensive Care Unit: a Randomized Controlled Prospective Trial.

Conditions
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Peripheral Venous Cannulation

Intervention / Treatment
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* Procedure: US guided dynamic needle tip positioning peripheral intravenous cannulation
* Procedure: Traditional peripheral intravenous cannulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Invasively ventilated Younger than 18 years Peripheral venous access required Difficult intravenous access (DIVA) score of 4 or greater (on a scale of 0-10 with higher scores implying more difficult access) Exclusion Criteria: Refusal to consent Research staff not available

Ages Eligible for Study
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Maximum Age: 18 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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ultrasound Guided Dynamic Needle Tip Positioning Technique<br>In this arm the US transducer, protected with a sterile cover and sterile gel will be placed in the short axis above the distal end of the selected vein, moving the probe to place the vein in the center of the ultrasound screen under the middle mark of the image. The catheter needle will be inserted close to the transducer. The needle tip will be visualized as a white dot on the ultrasound screen. Then, the transducer will be shifted slightly proximally until the white dot disappears from the screen. The needle and the transducer will be moved alternately toward the patient several times to visualize the needle tip in real time. After penetrating the anterior wall of the vein, these steps will be repeated a few more times with a smaller insertion angle to visualize the white dot in the vein. Finally, the outer catheter will be fully advanced and the needle core will be extracted. | Procedure: US guided dynamic needle tip positioning peripheral intravenous cannulation<br>* Catheterizations will be performed by one of three pediatric intensivists with vast experience in both traditional and US guided DNTP techniques for peripheral intravenous access. The operator will be allowed to independently choose which peripheral vein to cannulate. If necessary, patients will be given supplemental dose of sedation and analgesia in addition to the already given continuous infusions for invasive mechanical ventilation. Before puncture, the limb will be taped and maintained in an optimal position. A tourniquet will be placed proximal to the planned cannulation site. The site of puncture will be disinfected with Chlorhexidine gluconate 0.5% w/v, Alcohol 70% v/v. The choice of catheter will be left to the discretion of the operator. Available PIV cannulas include : 14 GA, 2X45 mm; 17 GA, 1.4X45 mm; 18 GA 1.2X45 mm; 20 GA 1X32mm BD Venflon™ and 24 GA, 0.7X19 mm; 26 GA 0.6X19 mm BD Neoflon™ (Becton Dickinson Infusion Therapy AB, Helsingborg, Sweden).<br>|
| Active Comparator: Traditional insertion group<br>For traditional insertion technique insertion attempt will be blind or tactile. Otherwise, the same protocol and measurements as elaborated for the US guided group will be applied. | Procedure: Traditional peripheral intravenous cannulation<br>* For traditional insertion technique insertion attempt will be blind or tactile.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success of peripheral IV cannulation on first attempt | Assessment of peripheral IV cannulation success on first attempt (Yes vs No) | 10 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall peripheral IV cannulation success rate | The overall success rate of peripheral intravenous cannulation within 3 attempts. | 10 minutes | 
| Time to successful peripheral IV cannulation | Defined as the time from first skin puncture to successful cannulation (minutes). | up to 10 minutes | 
| Number of attempts to success | Number of puncture attempts (1,2 or 3) needed for achieving a a successful cannulation | up to 10 minutes | 
| Inserted cannula diameter | Cannula diameter (in GA) successfully inserted | up to 10 minutes |