Saphenous Vein Cannulation in Infants and Small Children

Not Applicable

Completed

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

• Registration Number: NCT01924975
• Lead Sponsor: Satoshi Hanada

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2013-07
• Study First Submitted: 2013-08-14
• Study First Submitted QC: 2013-08-14
• Study First Posted: 2013-08-19
• Primary Completion: 2014-07
• Study Completion: 2014-07
• Results First Submitted: 2016-03-31
• Results First Submitted QC: 2016-03-31
• Results First Posted: 2016-05-04
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-25
• Last Update Posted: 2018-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 102

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ultrasound group	Saphenous vein cannulation	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.
Landmark group	Saphenous vein cannulation	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.
Landmark group	A 22 or 24 G intravenous catheter	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.
Ultrasound group	ultrasound with a linear transducer (L15-7io)	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.
Ultrasound group	A 22 or 24 G intravenous catheter	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.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With First Attempt Success of Saphenous Vein Cannulation	10 minutes

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University of Iowa Hospitals & Clinics; 🇺🇸 Iowa City, Iowa, United States