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Clinical Trials/NCT03181542
NCT03181542
Completed
Not Applicable

A Randomized Controlled Study of Efficacy of Infra Red Vein Illumination Versus Standard Technique

Milton S. Hershey Medical Center1 site in 1 country160 target enrollmentJuly 10, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Difficult Intravenous Access
Sponsor
Milton S. Hershey Medical Center
Enrollment
160
Locations
1
Primary Endpoint
Success Rate
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 10, 2017
End Date
October 29, 2020
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Priti G. Dalal

Professor of Anesthesiology & Perioperative Medicine

Milton S. Hershey Medical Center

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • Emergency procedures requiring anesthesia
  • ASA physical status 4
  • Patients with pre existing iv access

Outcomes

Primary Outcomes

Success Rate

Time Frame: 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 Outcomes

  • Time to Successful Insertion(When patient is in operating room and insertion of intravenous access line is performed)
  • The Number of Attempts(When patient is in operating room and insertion of intravenous access line is performed)

Study Sites (1)

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