Catheterization, Peripheral
Conditions
Keywords
Near-Infrared Vein Imaging, Difficult Venous Access
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.
Interventions
DEVICENear Infrared Vein Imaging
Use of NI vein imaging device for visualization of veins during peripheral IV placement
OTHERConventional IV placement
IV placement utilizing conventional methods
Sponsors
Lahey Clinic
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
15 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Conventional Method Placement of peripheral venous catheter using conventional methods
Conventional IV placement: IV placement utilizing conventional methods | 13 |
| 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 | 13 |
| 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 | 12 |
| Total | 38 |
Baseline characteristics
| Characteristic | Conventional Method | VeinViewer Visualization Only | Constant Imaging With VeinViewer | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 3 Participants | 4 Participants | 4 Participants | 11 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants | 9 Participants | 8 Participants | 27 Participants |
| Race and Ethnicity Not Collected | — | — | — | 0 Participants |
| Sex: Female, Male Female | 9 Participants | 7 Participants | 7 Participants | 23 Participants |
| Sex: Female, Male Male | 4 Participants | 6 Participants | 5 Participants | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 13 | 0 / 13 | 0 / 12 |
| other Total, other adverse events | 0 / 13 | 0 / 13 | 0 / 12 |
| serious Total, serious adverse events | 0 / 13 | 0 / 13 | 0 / 12 |
Outcome results
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)
Time frame: up to 30 minutes
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Conventional Method | Number of Participants With Successful Initial IV Placement | 10 Participants |
| VeinViewer Visualization Only | Number of Participants With Successful Initial IV Placement | 6 Participants |
| Constant Imaging With VeinViewer | Number of Participants With Successful Initial IV Placement | 6 Participants |