Infra Red Vein Visualization: Efficacy vs. Standard Technique

Difficult Intravenous Access Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03181542
• Other study ID #: STUDY00006768
• Status: Completed
• Phase: N/A
• Start date: July 10, 2017
• Est. completion date: October 29, 2020

Study information

• Verified date: November 2021
• Source: Milton S. Hershey Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: October 29, 2020
• Est. primary completion date: October 29, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 2 Years

Eligibility

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

Related Conditions & MeSH terms

• Difficult Intravenous Access

Intervention

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

Locations

Country	Name	City	State
United States	Milton S. Hershey Medical Center	Hershey	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Milton S. Hershey Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (6)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Rothbart A, Yu P, Müller-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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Success Rate	Success for insertion of intravenous access line will be determined by flushability with 5 ml of sterile normal saline	When patient is in operating room and insertion of intravenous access line has been confirmed to be successful, an average of 30 minutes
Secondary	The Number of Attempts	The number of attempts it takes for successful insertion of the intravenous access line	When patient is in operating room and insertion of intravenous access line is performed
Secondary	Time to Successful Insertion	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	When patient is in operating room and insertion of intravenous access line is performed