Infra Red Vein Visualization: Efficacy vs. Standard Technique

Overview

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)

Full Title of Study: “A Randomized Controlled Study of Efficacy of Infra Red Vein Illumination Versus Standard Technique”

Study Type

• Study Type: Interventional
• Study Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Primary Purpose: Supportive Care
  • Masking: None (Open Label)
• Study Primary Completion Date: October 29, 2020

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.

Interventions

• Device: Infrared illumination
  • Infrared illumination of veins using the FDA approved AccuVein (AccuVein, Inc., Huntington, NY) device.

Arms, Groups and Cohorts

• Experimental: 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
• No Intervention: Standard Technique
  • Standard vein location techniques will be used when inserting an intravenous access line

Clinical Trial Outcome Measures

Primary Measures

• 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 Measures

• The Number of Attempts
  • Time Frame: 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
• Time to Successful Insertion
  • Time Frame: 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: 2 Years

Are Healthy Volunteers Accepted: No

Investigator Details

• Lead Sponsor
  • Milton S. Hershey Medical Center
• Provider of Information About this Clinical Study
  • Principal Investigator: Priti G. Dalal, Professor of Anesthesiology & Perioperative Medicine – Milton S. Hershey Medical Center
• Overall Official(s)
  • Priti G Dalal, MD, Principal Investigator, Milton S. Hershey Medical Center

References

Kaddoum RN, Anghelescu DL, Parish ME, Wright BB, Trujillo L, Wu J, Wu Y, Burgoyne LL. A randomized controlled trial comparing the AccuVein AV300 device to standard insertion technique for intravenous cannulation of anesthetized children. Paediatr Anaesth. 2012 Sep;22(9):884-9. doi: 10.1111/j.1460-9592.2012.03896.x. Epub 2012 Jun 14.

Rothbart A, Yu P, Muller-Lobeck L, Spies CD, Wernecke KD, Nachtigall I. Peripheral intravenous cannulation with support of infrared laser vein viewing system in a pre-operation setting in pediatric patients. BMC Res Notes. 2015 Sep 21;8:463. doi: 10.1186/s13104-015-1431-2.

de Graaff JC, Cuper NJ, Mungra RA, Vlaardingerbroek K, Numan SC, Kalkman CJ. Near-infrared light to aid peripheral intravenous cannulation in children: a cluster randomised clinical trial of three devices. Anaesthesia. 2013 Aug;68(8):835-45. doi: 10.1111/anae.12294. Epub 2013 Jun 14.

Nafiu OO, Burke C, Cowan A, Tutuo N, Maclean S, Tremper KK. Comparing peripheral venous access between obese and normal weight children. Paediatr Anaesth. 2010 Feb;20(2):172-6. doi: 10.1111/j.1460-9592.2009.03198.x. Epub 2009 Nov 17.

Jacobson AF, Winslow EH. Variables influencing intravenous catheter insertion difficulty and failure: an analysis of 339 intravenous catheter insertions. Heart Lung. 2005 Sep-Oct;34(5):345-59. doi: 10.1016/j.hrtlng.2005.04.002.

Yen K, Riegert A, Gorelick MH. Derivation of the DIVA score: a clinical prediction rule for the identification of children with difficult intravenous access. Pediatr Emerg Care. 2008 Mar;24(3):143-7. doi: 10.1097/PEC.0b013e3181666f32.