Infra Red Vein Visualization: Efficacy vs. Standard Technique

NCT03181542 | Completed Results FDA Device

• 1 other identifier: STUDY00006768
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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)

Conditions

Difficult Intravenous Access

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• The Number of Attempts

  When patient is in operating room and insertion of intravenous access line is performed

• Time to Successful Insertion

  When patient is in operating room and insertion of intravenous access line is performed

Study Arms (2)

Infrared vein illumination

EXPERIMENTAL

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

Device: Infrared illumination

Standard Technique

NO INTERVENTION

Standard vein location techniques will be used when inserting an intravenous access line

Interventions

Infrared illumination DEVICE

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

Infrared vein illumination

Eligibility Criteria

• Age: Up to 2 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead

Study Sites (1)

Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

Related Publications (6)

• 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.

  PMID: 22694242 BACKGROUND

• 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.

  PMID: 26391665 BACKGROUND

• 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.

  PMID: 23763614 BACKGROUND

• 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.

  PMID: 19922428 BACKGROUND

• 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.

  PMID: 16157191 BACKGROUND

• 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.

  PMID: 18347490 BACKGROUND

Results Point of Contact

• Title: Dr Priti Dalal
• Organization: Penn State Hershey Medical Center

pdalal@pennstatehealth.psu.edu

717-531-6597

Study Officials

• Priti G Dalal, MD

  Milton S. Hershey Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Anesthesiology & Perioperative Medicine

Model Details: Randomized, controlled trial

Study Record Dates

• First Submitted: June 1, 2017
• First Posted: June 8, 2017
• Study Start: July 10, 2017
• Primary Completion: October 29, 2020
• Study Completion: October 29, 2020
• Last Updated: December 21, 2021
• Results First Posted: December 21, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)