Clinical trial NCT04262947: Efficacy of Near-Infrared Vein Imaging for Difficult IV Placement
Official title: The Efficacy of Near-Infrared Vein Imaging for the Success of Placing Peripheral Venous Catheters in Adults With Difficult Venous Access
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Catheterization, Peripheral
Keywords: Near-Infrared Vein Imaging
Difficult Venous Access
Lead sponsor: Lahey Clinic
Sponsor class: OTHER
First posted: 2020-02-10
Enrollment: 38
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: OTHER

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With Successful Initial IV Placement
timeFrame: up to 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Burlington
country: United States
facility: Lahey Clinic
state: Massachusetts
Study officials:
affiliation: Lahey Clinic
name: Thomas Schnelldorfer, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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. doi: 10.1109/memb.2005.1411359. No abstract available.
citation: 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.
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.
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. doi: 10.1007/s00431-016-2796-5. Epub 2016 Oct 26.
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.
citation: 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.
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.