Efficacy of Near-Infrared Vein Imaging for Difficult IV Placement

• Sponsor: Lahey Clinic (Other)
• Overall Status: Terminated
• CT.gov ID: NCT04262947
• Collaborator: (none)
• Enrollment: 38
• Location: 1
• Arms: 3
• Actual Duration (Months): 2.3
• Patients Per Site Per Month: 16.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Catheterization, Peripheral	Device: Near Infrared Vein Imaging; Other: Conventional IV placement	N/A

Detailed Description

The efficacy of NIR vein finders beyond the first line approach, particularly in patients that have failed conventional peripheral venous access methods or in patients that are expected to be a "difficult stick", is not established. Conflicting results have been reported in the pediatric literature regarding the subjective benefit of NIR light devices in patients with perceived difficult peripheral intravenous access. In addition, knowledge about the efficacy of these devices in the adult inpatient setting is mostly unknown. The aim of the present study is to address these knowledge gaps.

Study Design

• Study Type: Interventional
• Actual Enrollment: 38 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: The Efficacy of Near-Infrared Vein Imaging for the Success of Placing Peripheral Venous Catheters in Adults With Difficult Venous Access
• Actual Study Start Date: Jan 22, 2020
• Actual Primary Completion Date: Apr 1, 2020
• Actual Study Completion Date: Apr 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Conventional Method Placement of peripheral venous catheter using conventional methods	Other: Conventional IV placement; IV placement utilizing conventional methods
Experimental: VeinViewer Visualization Only 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; Use of NI vein imaging device for visualization of veins during peripheral IV placement; Other Names: VeinViewer Flex ; Other: Conventional IV placement; IV placement utilizing conventional methods
Experimental: Constant Imaging with VeinViewer Identification of the most suitable target and placement of a peripheral venous catheter under constant imaging with a VeinViewer	Device: Near Infrared Vein Imaging; Use of NI vein imaging device for visualization of veins during peripheral IV placement; Other Names: VeinViewer Flex

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Successful Initial IV Placement [up to 30 minutes]

   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)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 15 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Lahey Clinic	Burlington	Massachusetts	United States	01805

Sponsors and Collaborators

• Lahey Clinic

Investigators

• Principal Investigator: Thomas Schnelldorfer, MD, Lahey Clinic

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Dec 17, 2019

More Information

Publications

• 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.
• 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.
• 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. Review.
• Jöhr 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. Review.
• 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. Review.
• 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.
• 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. Epub 2016 Oct 26. Review.
• 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.

• Responsible Party: Lahey Clinic
• ClinicalTrials.gov Identifier: NCT05051020
• Other Study ID Numbers: 20193166; NCT05051020
• First Posted: Feb 10, 2020
• Last Update Posted: Mar 4, 2022
• Last Verified: Jan 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by Lahey Clinic: Near-Infrared Vein Imaging; Difficult Venous Access

Study Results

Participant Flow

Arm/Group Title	Conventional Method	VeinViewer Visualization Only	Constant Imaging With VeinViewer
Arm/Group Description	Placement of peripheral venous catheter using conventional methods Conventional IV placement: IV placement utilizing conventional methods	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 Near Infrared Vein Imaging: Use of NI vein imaging device for visualization of veins during peripheral IV placement Conventional IV placement: IV placement utilizing conventional methods	Identification of the most suitable target and placement of a peripheral venous catheter under constant imaging with a VeinViewer Near Infrared Vein Imaging: Use of NI vein imaging device for visualization of veins during peripheral IV placement
Period Title: Overall Study
STARTED	13	13	12
COMPLETED	13	13	12
NOT COMPLETED	0	0	0

Baseline Characteristics

Arm/Group Title	Conventional Method	VeinViewer Visualization Only	Constant Imaging With VeinViewer	Total
Arm/Group Description	Placement of peripheral venous catheter using conventional methods Conventional IV placement: IV placement utilizing conventional methods	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 Near Infrared Vein Imaging: Use of NI vein imaging device for visualization of veins during peripheral IV placement Conventional IV placement: IV placement utilizing conventional methods	Identification of the most suitable target and placement of a peripheral venous catheter under constant imaging with a VeinViewer Near Infrared Vein Imaging: Use of NI vein imaging device for visualization of veins during peripheral IV placement	Total of all reporting groups
Overall Participants	13	13	12	38
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%	0 0%
Between 18 and 65 years	10 76.9%	9 69.2%	8 66.7%	27 71.1%
>=65 years	3 23.1%	4 30.8%	4 33.3%	11 28.9%
Sex: Female, Male (Count of Participants)
Female	9 69.2%	7 53.8%	7 58.3%	23 60.5%
Male	4 30.8%	6 46.2%	5 41.7%	15 39.5%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Successful Initial IV Placement
Description	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)
Time Frame	up to 30 minutes

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Conventional Method	VeinViewer Visualization Only	Constant Imaging With VeinViewer
Arm/Group Description	Placement of peripheral venous catheter using conventional methods Conventional IV placement: IV placement utilizing conventional methods	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 Near Infrared Vein Imaging: Use of NI vein imaging device for visualization of veins during peripheral IV placement Conventional IV placement: IV placement utilizing conventional methods	Identification of the most suitable target and placement of a peripheral venous catheter under constant imaging with a VeinViewer Near Infrared Vein Imaging: Use of NI vein imaging device for visualization of veins during peripheral IV placement
Measure Participants	13	13	12
Count of Participants [Participants]	10 76.9%	6 46.2%	6 50%

Adverse Events

Time Frame	During hospital stay, an average of 4 days
Arm/Group Title	Conventional Method		VeinViewer Visualization Only		Constant Imaging With VeinViewer
Arm/Group Description	Placement of peripheral venous catheter using conventional methods Conventional IV placement: IV placement utilizing conventional methods		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 Near Infrared Vein Imaging: Use of NI vein imaging device for visualization of veins during peripheral IV placement Conventional IV placement: IV placement utilizing conventional methods		Identification of the most suitable target and placement of a peripheral venous catheter under constant imaging with a VeinViewer Near Infrared Vein Imaging: Use of NI vein imaging device for visualization of veins during peripheral IV placement
All Cause Mortality
	Conventional Method		VeinViewer Visualization Only		Constant Imaging With VeinViewer
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/13 (0%)		0/13 (0%)		0/12 (0%)
Serious Adverse Events
	Conventional Method		VeinViewer Visualization Only		Constant Imaging With VeinViewer
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/13 (0%)		0/13 (0%)		0/12 (0%)
Other (Not Including Serious) Adverse Events
	Conventional Method		VeinViewer Visualization Only		Constant Imaging With VeinViewer
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/13 (0%)		0/13 (0%)		0/12 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.