Saphenous Vein Cannulation in Infants and Small Children

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

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).

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 102
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa Hospitals & Clinics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 4 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Landmark group; 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; Intravenous cannulation to saphenous vein; Device: A 22 or 24 G intravenous catheter
Active Comparator: Ultrasound group; 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; Intravenous cannulation to saphenous vein; Device: A 22 or 24 G intravenous catheter; Device: ultrasound with a linear transducer (L15-7io); Portable, bed-side ultrasound to detect saphenous vein

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Satoshi Hanada
• Investigators: Principal Investigator: Satoshi Hanada, MD, University of Iowa Hospitals & Clinics

Publications and helpful links

General Publications

• Triffterer L, Marhofer P, Willschke H, Machata AM, Reichel G, Benkoe T, Kettner SC. Ultrasound-guided cannulation of the great saphenous vein at the ankle in infants. Br J Anaesth. 2012 Feb;108(2):290-4. doi: 10.1093/bja/aer334. Epub 2011 Oct 27.
• Riera A, Langhan M, Northrup V, Santucci K, Chen L. Remember the saphenous: ultrasound evaluation and intravenous site selection of peripheral veins in young children. Pediatr Emerg Care. 2011 Dec;27(12):1121-5. doi: 10.1097/PEC.0b013e31823ab926.
• Joshi M, Wilson G, Engelhardt T. Comparison of landmark technique and ultrasound guidance for localisation of long saphenous vein in infants and children. Emerg Med J. 2010 Jun;27(6):443-5. doi: 10.1136/emj.2008.069310.

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (Actual): July 1, 2014
• Study Completion (Actual): July 1, 2014

Study Registration Dates

• First Submitted: August 14, 2013
• First Submitted That Met QC Criteria: August 14, 2013
• First Posted (Estimate): August 19, 2013

Study Record Updates

• Last Update Posted (Actual): January 23, 2018
• Last Update Submitted That Met QC Criteria: December 25, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: V-line study