Trial Outcomes & Findings for ivWatch Model 400: Device Validation for Non-Infiltrated Tissues (NCT NCT02120443)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

43 participants

Primary outcome timeframe

24 hours

Results posted on

2014-07-02

Participant Flow

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	43
Overall Study COMPLETED	43
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

ivWatch Model 400: Device Validation for Non-Infiltrated Tissues

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Non-Infiltrated Tissue n=43 Participants 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.
Age, Continuous	31.4 years STANDARD_DEVIATION 13.9 • n=5 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	42 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Sex: Female, Male Female	18 Participants n=5 Participants
Sex: Female, Male Male	25 Participants n=5 Participants
Region of Enrollment United States	43 participants n=5 Participants
Body Mass Index	26.3 kg/m^2 STANDARD_DEVIATION 5.4 • n=5 Participants
Skin Pigmentation	1.84 units on a scale STANDARD_DEVIATION 0.84 • n=5 Participants

PRIMARY outcome

Timeframe: 24 hours

Population: Three subjects were excluded from analysis due to significant protocol deviations.

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.

Outcome measures

Outcome measures
Measure	Non-Infiltrated Tissue n=40 Participants 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.
Normal Tissue Red Notification Rate	0.24 red notifications per day Interval 0.11 to 0.45

SECONDARY outcome

Timeframe: 24 hours

Population: Three participants were excluded due to significant protocol deviations.

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.

Outcome measures

Outcome measures
Measure	Non-Infiltrated Tissue n=40 Participants 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.
Normal Tissue Yellow Notification Rate	0.51 yellow notifications per day Interval 0.31 to 0.79

SECONDARY outcome

Timeframe: 24 hours

Population: Three participants were excluded for significant protocol deviations.

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.

Outcome measures

Outcome measures
Measure	Non-Infiltrated Tissue n=40 Participants 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.
Significant Skin Irritation or Disruption to Skin Integrity	0 IV sites Interval 0.0 to 0.0881

Adverse Events

Non-Infiltrated Tissue

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Garret T. Bonnema

ivWatch, LLC

Phone: 1.855.489.2824

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place