A Randomized Controlled Study of Efficacy of Infra Red Vein Illumination Versus Standard Technique
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 160
- Locations
- 1
- Primary Endpoint
- Success Rate
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- — to 2 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Infrared vein 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
Intervention: Infrared illumination (Device)
Standard Technique
Standard vein location techniques will be used when inserting an intravenous access line
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)
Investigators
Priti G. Dalal
Professor of Anesthesiology & Perioperative Medicine
Milton S. Hershey Medical Center