Infiltration of Peripheral IV Therapy
Conditions
Keywords
infiltration, extravasation, peripheral intravenous therapy
Brief summary
A single arm study of 40 adult volunteers to assess the safety and efficacy of the ivWatch Model 400 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
* Informed consent * Pass health screen * 18 years or older
Exclusion criteria
* Fail health screen
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Normal Tissue Red Notification Rate | 24 hours | The ivWatch Model 400 issues red 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 the Clopper-Pearson method. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Normal Tissue Yellow Notification Rate | 24 hours | The ivWatch Model 400 issues yellow notifications to communicate the need for a clinician to check an IV site. A yellow notification suggests an increased likelihood that an IV infiltration may be occurring, although at a lower likelihood relative to a red notification. This measure describes the average number of yellow notifications issued by the ivWatch device in a given day when monitoring normal, non-infiltrated tissues. The 95% confidence interval for the yellow notification rate was calculated using the Clopper-Pearson method. |
| Significant Skin Irritation or Disruption to Skin Integrity | 24 hours | The number of IV sites with significant skin irritation or disruption to skin integrity assessed at the end of the study. The Clopper-Pearson method was used for estimating the binomial proportion confidence interval. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Non-Infiltrated Tissue The ivWatch Model 400 monitored a common peripheral IV site over a 24 hour observation period.
ivWatch Model 400: The ivWatch Model 400 monitored tissue at common IV sites over a 24 hour period. | 43 |
| Total | 43 |
Baseline characteristics
| Characteristic | Non-Infiltrated Tissue |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 42 Participants |
| Age, Continuous | 31.4 years STANDARD_DEVIATION 13.9 |
| Body Mass Index | 26.3 kg/m^2 STANDARD_DEVIATION 5.4 |
| Region of Enrollment United States | 43 participants |
| Sex: Female, Male Female | 18 Participants |
| Sex: Female, Male Male | 25 Participants |
| Skin Pigmentation | 1.84 units on a scale STANDARD_DEVIATION 0.84 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 43 |
| serious Total, serious adverse events | 0 / 43 |
Outcome results
Primary
Normal Tissue Red Notification Rate
The ivWatch Model 400 issues red 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 the Clopper-Pearson method.
Time frame: 24 hours
Population: Three subjects were excluded from analysis due to significant protocol deviations.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Non-Infiltrated Tissue | Normal Tissue Red Notification Rate | 0.24 red notifications per day |
Secondary
Normal Tissue Yellow Notification Rate
The ivWatch Model 400 issues yellow notifications to communicate the need for a clinician to check an IV site. A yellow notification suggests an increased likelihood that an IV infiltration may be occurring, although at a lower likelihood relative to a red notification. This measure describes the average number of yellow notifications issued by the ivWatch device in a given day when monitoring normal, non-infiltrated tissues. The 95% confidence interval for the yellow notification rate was calculated using the Clopper-Pearson method.
Time frame: 24 hours
Population: Three participants were excluded due to significant protocol deviations.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Non-Infiltrated Tissue | Normal Tissue Yellow Notification Rate | 0.51 yellow notifications per day |
Secondary
Significant Skin Irritation or Disruption to Skin Integrity
The number of IV sites with significant skin irritation or disruption to skin integrity assessed at the end of the study. The Clopper-Pearson method was used for estimating the binomial proportion confidence interval.
Time frame: 24 hours
Population: Three participants were excluded for significant protocol deviations.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Non-Infiltrated Tissue | Significant Skin Irritation or Disruption to Skin Integrity | 0 IV sites |