Saphenous Vein Cannulation in Infants and Small Children

Satoshi Hanada

Status: Completed

Conditions: Saphenous Vein Cannulation

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

Study type: Interventional

Funder types: Other

Identifiers

NCT01924975

V-line study

Details and patient eligibility

About

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).

Enrollment: 102 patients

Sex: All

Ages: Under 4 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Pediatric patient undergoing scheduled surgery which requires venous cannulation.
2. Term neonates and children < 4 years old weighing >/= 3 kg

Exclusion criteria

1. Patient with visible saphenous vein
2. Patient with no detectable saphenous vein under ultrasound
3. Patient with a skin wound or infection around puncture site
4. Patient with recent venous puncture at the puncture site (less than 1 month)
5. Patient with thrombus in saphenous vein or hematoma formation around the vein detected by ultrasound.
6. Patient with any emergency surgery

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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102 participants in 2 patient groups

Landmark group

Active Comparator group

Description:

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.

Treatment:

Procedure: Saphenous vein cannulation

Device: A 22 or 24 G intravenous catheter

Ultrasound group

Active Comparator group

Description:

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.

Treatment:

Device: ultrasound with a linear transducer (L15-7io)

Procedure: Saphenous vein cannulation

Device: A 22 or 24 G intravenous catheter