Infiltration of Peripheral IV Therapy
Conditions
Keywords
motion
Brief summary
A single arm study of 20 adult volunteers to assess the safety and efficacy of the ivWatch sensors when observing non-infiltrated (normal) tissues at common peripheral IV therapy sites.
Interventions
DEVICEivWatch Model 400
The ivWatch Model 400 monitored tissue at common IV sites over a 24 hour period.
Sponsors
ivWatch, LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 18 years of age or older * Healthy individual, verified by an eligible designation on the Health History Form
Exclusion criteria
* Currently enrolled in another clinical trial * Currently pregnant or trying to become pregnant * Serious and uncontrolled medical condition * Tattoo(s), scarring, or bruising that severely limits vein visualization at a sensor monitoring location * Medical adhesive allergy * Sleepwalking occurrence in the last year * Current drug/alcohol dependence * Sick or had an infection in the last 14 days * Hospitalized in the last 14 days * Fever at the time of study visit (≥100.4°F)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Red Check IV Notification Rate Per Day | 24 Hours | The ivWatch Model 400 issues Check IV notifications to communicate the need for a clinician to check an IV site. A red notification suggests an increased likelihood that an IV infiltration may be occurring, with a greater likelihood relative to a yellow notification. This measure describes the average number of red notifications issued by the ivWatch device in a given day when monitoring normal, non-infiltrated tissues. The 95% confidence interval for the red notification rate was calculated using a negative binomial regression model. |
Countries
United States
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 48 years |
| Sex: Female, Male Female | 13 Participants |
| Sex: Female, Male Male | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 20 |
| other Total, other adverse events | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 |
Outcome results
None listed