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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional Method | Active Comparator | Placement of peripheral venous catheter using conventional methods |
|
| 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 |
|
| Constant Imaging with VeinViewer | Experimental | Identification of the most suitable target and placement of a peripheral venous catheter under constant imaging with a VeinViewer |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Near Infrared Vein Imaging | Device | Use of NI vein imaging device for visualization of veins during peripheral IV placement |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Schnelldorfer, MD | Lahey Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lahey Clinic | Burlington | Massachusetts | 01805 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19898521 | Background | 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. | |
| 15825855 | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Conventional Method | Placement of peripheral venous catheter using conventional methods Conventional IV placement: IV placement utilizing conventional methods |
| FG001 | 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 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 |
| FG002 | Constant Imaging With VeinViewer | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Conventional Method | Placement of peripheral venous catheter using conventional methods Conventional IV placement: IV placement utilizing conventional methods |
| BG001 | VeinViewer Visualization Only |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | 38 patients is total number of study population |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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) | Posted | Count of Participants | Participants | up to 30 minutes |
|
During hospital stay, an average of 4 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Conventional Method | Placement of peripheral venous catheter using conventional methods Conventional IV placement: IV placement utilizing conventional methods |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Thomas Schnelldorfer | Lahey Hospital and Medical Center | 781-744-5100 | thomas.schnelldorfer@lahey.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 17, 2019 | Jan 5, 2022 | Prot_SAP_000.pdf |
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|
| Conventional IV placement | Other | IV placement utilizing conventional methods |
|
| 23384732 | 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. |
| 25335191 | 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. |
| 27785562 | 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. |
| 23823270 | 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. |
| 25827277 | 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. |
| 27100437 | 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. |
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
| BG002 | Constant Imaging With VeinViewer | 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 |
| BG003 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| OG002 | Constant Imaging With VeinViewer | 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 |
|
|
| 0 |
| 13 |
| 0 |
| 13 |
| 0 |
| 13 |
| EG001 | 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 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 | 0 | 13 | 0 | 13 | 0 | 13 |
| EG002 | Constant Imaging With VeinViewer | 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 | 0 | 12 | 0 | 12 | 0 | 12 |
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| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|