Efficacy of Near-Infrared Vein Imaging for Difficult IV Placement

NCT04262947 | Terminated Results FDA Device

• 1 other identifier: 20193166
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this project is to define the effectiveness and therefore the role of NIR vein finders in adult patients with difficult peripheral venous access. The specific objective of the proposed randomized controlled trial is to test the clinical success rate of placing peripheral venous catheters in 'difficult' access patients using traditional peripheral venous catheter placement compared to two established methods utilizing NIR vein imaging. The investigators hypothesize that the capability to successfully place lasting peripheral venous catheters is increased with the adjunct of the imaging technology, reducing the number of failed needle sticks, reducing the number of peripheral venous catheters placed throughout a patient's hospital stay, and reducing the need for more invasive catheters such as PICC lines.

Conditions

Catheterization, Peripheral

Keywords

Near-Infrared Vein Imaging; Difficult Venous Access

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Successful Initial IV Placement

  Rate of successful initial placement of a peripheral venous catheter (investigators have up to 30 minutes or ONE attempt before the study allows for change of technique to the preference of the Vascular Access Team member)

  up to 30 minutes

Study Arms (3)

Conventional Method

ACTIVE COMPARATOR

Placement of peripheral venous catheter using conventional methods

Other: Conventional IV placement

VeinViewer Visualization Only

EXPERIMENTAL

Use of a VeinViewer to visualize the most suitable target. Once the target has been identified and marked, the device will be placed aside and the peripheral venous catheter will be placed using conventional methods

Device: Near Infrared Vein Imaging; Other: Conventional IV placement

Constant Imaging with VeinViewer

EXPERIMENTAL

Identification of the most suitable target and placement of a peripheral venous catheter under constant imaging with a VeinViewer

Device: Near Infrared Vein Imaging

Interventions

Near Infrared Vein Imaging DEVICE

Use of NI vein imaging device for visualization of veins during peripheral IV placement

Also known as: VeinViewer Flex

Constant Imaging with VeinViewer; VeinViewer Visualization Only

Conventional IV placement OTHER

IV placement utilizing conventional methods

Conventional Method; VeinViewer Visualization Only

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• non-pediatric in-hospital patients (≥15 years of age, inpatient and outpatient setting)
• willing to provide research authorization
• scheduled and consented to undergo peripheral venous cannulation of one of the upper extremities to be performed by one of the members of the Vascular Access Team
• determined to be a difficult peripheral venous access defined by one of the following criteria in alignment to the A-DIVA scale to be assessed by one of the members of the Vascular Access Team \[8\]:
• failed inspection for more than one visible or palpable suitable vein through conventional methods
• failed at least one attempt of peripheral venous cannulation through any methods
• history of difficult peripheral venous access
• greatest diameter of target vein less than 3mm determined by conventional methods

You may not qualify if:

• clinical contraindication for placement of peripheral venous catheter, including:
• severe bilateral upper extremity edema
• severe bilateral upper extremity skin burn
• severe bilateral upper extremity cellulitis
• history of bilateral axillary lymphadenectomy
• known severe cardiovascular or pulmonary compromise demanding minimization of procedure time, such as:
• severe shock with severe cardiovascular instability
• active CPR
• major uncontrolled hemorrhage
• any condition for which the primary healthcare provider is requesting emergent venous access
• scheduled PICC or midline catheter placement
• non-English-speaking patients if an interpreter is not available
• prisoner and any individual involuntarily confined or detained in a penal institution
• impaired capacity to make informed medical decisions

Sponsors & Collaborators

• Lahey Clinic: lead

Study Sites (1)

Lahey Clinic

Burlington, Massachusetts, 01805, United States

Location

Related Publications (8)

• Smith AM, Mancini MC, Nie S. Bioimaging: second window for in vivo imaging. Nat Nanotechnol. 2009 Nov;4(11):710-1. doi: 10.1038/nnano.2009.326.

  PMID: 19898521 BACKGROUND

• Kim JG, Xia M, Liu H. Extinction coefficients of hemoglobin for near-infrared spectroscopy of tissue. IEEE Eng Med Biol Mag. 2005 Mar-Apr;24(2):118-21. doi: 10.1109/memb.2005.1411359. No abstract available.

  PMID: 15825855 BACKGROUND

• Chiao FB, Resta-Flarer F, Lesser J, Ng J, Ganz A, Pino-Luey D, Bennett H, Perkins C Jr, Witek B. Vein visualization: patient characteristic factors and efficacy of a new infrared vein finder technology. Br J Anaesth. 2013 Jun;110(6):966-71. doi: 10.1093/bja/aet003. Epub 2013 Feb 5.

  PMID: 23384732 BACKGROUND

• Guillon P, Makhloufi M, Baillie S, Roucoulet C, Dolimier E, Masquelier AM. Prospective evaluation of venous access difficulty and a near-infrared vein visualizer at four French haemophilia treatment centres. Haemophilia. 2015 Jan;21(1):21-6. doi: 10.1111/hae.12513. Epub 2014 Oct 21.

  PMID: 25335191 BACKGROUND

• Park JM, Kim MJ, Yim HW, Lee WC, Jeong H, Kim NJ. Utility of near-infrared light devices for pediatric peripheral intravenous cannulation: a systematic review and meta-analysis. Eur J Pediatr. 2016 Dec;175(12):1975-1988. doi: 10.1007/s00431-016-2796-5. Epub 2016 Oct 26.

  PMID: 27785562 BACKGROUND

• Heinrichs J, Fritze Z, Klassen T, Curtis S. A systematic review and meta-analysis of new interventions for peripheral intravenous cannulation of children. Pediatr Emerg Care. 2013 Jul;29(7):858-66. doi: 10.1097/PEC.0b013e3182999bcd.

  PMID: 23823270 BACKGROUND

• Johr M, Berger TM. Venous access in children: state of the art. Curr Opin Anaesthesiol. 2015 Jun;28(3):314-20. doi: 10.1097/ACO.0000000000000181.

  PMID: 25827277 BACKGROUND

• Loon FHJV, Puijn LAPM, Houterman S, Bouwman ARA. Development of the A-DIVA Scale: A Clinical Predictive Scale to Identify Difficult Intravenous Access in Adult Patients Based on Clinical Observations. Medicine (Baltimore). 2016 Apr;95(16):e3428. doi: 10.1097/MD.0000000000003428.

  PMID: 27100437 BACKGROUND

Results Point of Contact

• Title: Thomas Schnelldorfer
• Organization: Lahey Hospital and Medical Center

thomas.schnelldorfer@lahey.org

781-744-5100

Study Officials

• Thomas Schnelldorfer, MD

  Lahey Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2020
• First Posted: February 10, 2020
• Study Start: January 22, 2020
• Primary Completion: April 1, 2020
• Study Completion: April 1, 2020
• Last Updated: March 4, 2022
• Results First Posted: March 4, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)