MedDataX Logo

Infra Red Vein Visualization: Efficacy vs. Standard Technique

NCT ID: NCT03181542

Last Updated: 2021-12-21

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-10

Study Completion Date

2020-10-29

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Difficult Intravenous Access

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized, controlled trial
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Group Type EXPERIMENTAL

Infrared illumination

Intervention Type DEVICE

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

Standard Technique

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Infrared illumination

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

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Maximum Eligible Age

2 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Milton S. Hershey Medical Center

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Priti G. Dalal

Professor of Anesthesiology & Perioperative Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Priti G Dalal, MD

Role: PRINCIPAL_INVESTIGATOR

Milton S. Hershey Medical Center

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Milton S. Hershey Medical Center

Hershey, Pennsylvania, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 22694242 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26391665 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23763614 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19922428 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16157191 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18347490 (View on PubMed)

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

STUDY00006768

Identifier Type: -

Identifier Source: org_study_id