Infra Red Vein Visualization: Efficacy vs. Standard Technique

Not Applicable

Completed

• Conditions: Difficult Intravenous Access
• Interventions: Device: Infrared illumination

• Registration Number: NCT03181542
• Lead Sponsor: Milton S. Hershey Medical Center

Brief Summary

The objective of the study is to assess the efficacy of the vein visualization device AccuVein (AccuVein, Inc., Huntington, NY) in comparison to a standard technique for establishing intravenous (iv) access in the infant and toddler population (\<2years)

Detailed Description

The objective of this project is to compare the iv success rate using the FDA approved Accuvein device for vein illumination versus not using the device, for infants/toddlers undergoing surgery at Penn State Children's Hospital with an ASA physical status 1, 2, or 3. After obtaining informed consent, the infant will be randomized to the vein illuminatin or standard group based on a computer generated number.

Study Timeline

• Study First Submitted: 2017-06-01
• Study First Submitted QC: 2017-06-07
• Study First Posted: 2017-06-08
• Study Start: 2017-07-10
• Primary Completion: 2020-10-29
• Study Completion: 2020-10-29
• Results First Submitted: 2021-10-15
• Status Verified: 2021-11
• Results First Submitted QC: 2021-11-22
• Last Update Submitted: 2021-11-22
• Results First Posted: 2021-12-21
• Last Update Posted: 2021-12-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

1. Children(<2year) undergoing anesthesia procedures at Penn State Health, Hershey Medical Center and Penn State Children's Hospital
2. ASA physical status 1,2 or 3

Exclusion Criteria

1. Emergency procedures requiring anesthesia
2. ASA physical status 4
3. Patients with pre existing iv access

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Infrared vein illumination	Infrared illumination	Infrared illumination of veins, using the FDA approved AccuVein device, will be used to assist in vein location when inserting an intravenous access line

Primary Outcome Measures

Name	Time	Method
Success Rate	When patient is in operating room and insertion of intravenous access line has been confirmed to be successful, an average of 30 minutes	Success for insertion of intravenous access line will be determined by flushability with 5 ml of sterile normal saline

Secondary Outcome Measures

Name	Time	Method
Time to Successful Insertion	When patient is in operating room and insertion of intravenous access line is performed	The time to successful insertion of the intravenous access line will be measured from the first time that the canula touches the skin to until successful iv access is established
The Number of Attempts	When patient is in operating room and insertion of intravenous access line is performed	The number of attempts it takes for successful insertion of the intravenous access line

Trial Locations

Locations (1)

Milton S. Hershey Medical Center; 🇺🇸 Hershey, Pennsylvania, United States