Near-infrared Vein Imaging for Peripheral IV Placement

Catheterization, Peripheral Clinical Trial

Official title:

The Efficacy of Near-Infrared Vein Imaging for the Success of Placing Peripheral Venous Catheters in Adults With Difficult Venous Access

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05051020
• Other study ID #: 0001
• Status: Terminated
• Phase: N/A
• Start date: January 22, 2020
• Est. completion date: April 1, 2020

Study information

• Verified date: August 2021
• Source: Lahey Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 38
• Est. completion date: April 1, 2020
• Est. primary completion date: April 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 15 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Catheterization, Peripheral

Intervention

Device:
• Near Infrared Vein Imaging
Use of NI vein imaging device for visualization of veins during peripheral IV placement

Other:
• Conventional IV placement
IV placement utilizing conventional methods

Locations

Country	Name	City	State
United States	Lahey Clinic	Burlington	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Lahey Clinic

Country where clinical trial is conducted

United States, 

References & Publications (8)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	15 minutes
Secondary	Number Required Needle Sticks	Number of required needle sticks before successful placement of a peripheral venous catheter	15 minutes
Secondary	Method Ultimately Resulting in Successful IV Placement	Rate of success for each method of peripheral IV placement. This includes conventional methods with no near-infrared imaging device usage, use of the near-infrared device for visualization and target marking only and placement of IV via conventional methods, or use of near-infrared device for constant visualization during vein visualization and IV placement.	15 minutes
Secondary	Vein Visualization	Number of visible veins suitable for cannulation (each continuous vein will be counted as one cannulation site)	15 minutes
Secondary	Gauge Size	IV catheter gauge size utilized after completion of IV cannulation	15 minutes
Secondary	Target Vein Location	Target vein location (bend of the elbow, forearm, back of hand, other) and side of extremity (right vs. left)	15 minutes
Secondary	Use of Warming of Arms Before IV Placement	This measure looks at whether or not warming of the arms was performed before peripheral IV placement to aid in vein visualization.	15 minutes
Secondary	Length of Procedure	Procedure time	15 minutes
Secondary	Complications	Rates of procedure associated complications	3 days
Secondary	Impact of Experience	Vascular Access Team member experience (years in practice).	15 minutes
Secondary	Patient Subjective Experience of Peripheral IV Placement	Patient survey on IV placement satisfaction. Satisfaction rating from Very Satisfied to Very Dissatisfied.	15 minutes
Secondary	Vascular Access Team member Subjective Experience of Peripheral IV Placement	Vascular Access Team member survey regarding difficulty of vein visualization and subsequent IV placement. Difficulty of IV visualization and placement rated from Very Difficult to Very Easy.	15 minutes
Secondary	Vascular Access Team member Subjective Experience with Vein Imaging Device	Vascular Access Team member survey regarding helpfulness of the near-infrared vein imaging device if used. If vein imaging device was used, asked if it was helpful and rated from Strongly Agree to Strongly Disagree.	15 minutes