Vascular Access Complication
Conditions
Brief summary
This study will look at the performance capabilities of software for VeinViewer.
Detailed description
This study will look at the performance capabilities of future software for VeinViewer.
Interventions
DEVICEVeinViewer
Updated software on the VeinViewer device will be used to project an image of the vasculature on the skin.
Sponsors
Christie Medical Holdings, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Must be 18 years of age or older 2. Must be considered to be in overall good health by investigator 3. Must pass all prescreening questions 4. Must be able to read and understand English
Exclusion criteria
1. Presence of tattoos, scarring, and/or extensive hair in the areas to be assessed for cannulation. 2. IV cannulation in the arms or hands in the previous 4 weeks.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants for Whom Successful Visualization of Vasculature Was Achieved | One day |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| VeinViewer Vascular imaging technology will be used to visualize peripheral vasculature.
VeinViewer | 62 |
| Total | 62 |
Baseline characteristics
| Characteristic | VeinViewer |
|---|---|
| Age, Continuous | 37.5 Years STANDARD_DEVIATION 10.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 62 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Fitzpatrick | 20.2 Points STANDARD_DEVIATION 7 |
| Height | 168.7 CM STANDARD_DEVIATION 10.5 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 7 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 53 Participants |
| Sex: Female, Male Female | 21 Participants |
| Sex: Female, Male Male | 41 Participants |
| Weight | 83.2 kg STANDARD_DEVIATION 17.6 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 62 |
| serious Total, serious adverse events | 0 / 62 |
Outcome results
Primary
Number of Participants for Whom Successful Visualization of Vasculature Was Achieved
Time frame: One day
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| VeinViewer | Number of Participants for Whom Successful Visualization of Vasculature Was Achieved | 62 participants |