Saphenous Vein Cannulation in Infants and Small Children

Study Overview
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Brief Summary
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The purpose of this study is to compare the two different saphenous vein cannulation techniques; real-time ultrasound image-guided technique (Ultrasound group) vs. traditional landmark technique (Landmark group).

Official Title
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Ultrasound-image Guided Versus Traditional Landmark Technique for Saphenous Vein Cannulation in Infants and Small Children

Conditions
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Saphenous Vein Cannulation

Intervention / Treatment
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* Procedure: Saphenous vein cannulation
* Device: ultrasound with a linear transducer (L15-7io)
* Device: A 22 or 24 G intravenous catheter


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pediatric patient undergoing scheduled surgery which requires venous cannulation. Term neonates and children < 4 years old weighing >/= 3 kg Exclusion Criteria: Patient with visible saphenous vein Patient with no detectable saphenous vein under ultrasound Patient with a skin wound or infection around puncture site Patient with recent venous puncture at the puncture site (less than 1 month) Patient with thrombus in saphenous vein or hematoma formation around the vein detected by ultrasound. Patient with any emergency surgery

Ages Eligible for Study
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Maximum Age: 4 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: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Landmark group<br>An operator is not allowed to use an ultrasound. A 22 or 24 G catheter will be advanced blindly toward the expected location of the saphenous vein at the level of the medial malleolus. Once blood appears in the hub, then the catheter will be advanced into the saphenous vein. | Procedure: Saphenous vein cannulation<br>* Intravenous cannulation to saphenous vein<br>Device: A 22 or 24 G intravenous catheter<br> <br> |
| Active Comparator: Ultrasound group<br>An operator will identify the saphenous vein by using ultrasound with a linear transducer (L15-7io) in short axis view. A 22 or 24 G catheter will be advanced until the tip of the needle is seen on the ultrasound image. The needle is then advanced until blood appears in the hub. The catheter is then advanced into the saphenous vein. | Procedure: Saphenous vein cannulation<br>* Intravenous cannulation to saphenous vein<br>Device: ultrasound with a linear transducer (L15-7io)<br>* Portable, bed-side ultrasound to detect saphenous vein<br>Device: A 22 or 24 G intravenous catheter<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With First Attempt Success of Saphenous Vein Cannulation |  | 10 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Success of Saphenous Vein Cannulation Within 3 Attempts of Needle Insertion, or a 10 Minute Time Period. |  | 10 minutes | 
| Time Required for Overall Successful Venous Cannulation. |  | 10 minutes |