ivWatch Model 400: Device Validation for Non-Infiltrated Tissues

• ClinicalTrials.gov Identifier: NCT02120443
• Recruitment Status: Completed
• First Posted: April 22, 2014
• Results First Posted: June 23, 2014
• Last Update Posted: July 2, 2014
• Sponsor: ivWatch, LLC
• Information provided by (Responsible Party): Garret Bonnema, ivWatch, LLC

• Study Type: Interventional
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Diagnostic
• Condition: Infiltration of Peripheral IV Therapy
• Intervention: Device: ivWatch Model 400
• Enrollment: 43

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	Non-Infiltrated Tissue
Arm/Group Description	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.
Period Title: Overall Study
Started	43
Completed	43
Not Completed	0

Baseline Characteristics

Arm/Group Title		Non-Infiltrated Tissue
Arm/Group Description		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 Number of Baseline Participants		43
Baseline Analysis Population Description		[Not Specified]
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	43 participants
		31.4 (13.9)
Age, Categorical; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	43 participants
	<=18 years	0 0.0%
	Between 18 and 65 years	42 97.7%
	>=65 years	1 2.3%
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	43 participants
	Female	18 41.9%
	Male	25 58.1%
Region of Enrollment; Measure Type: Number; Unit of measure: Participants
United States	Number Analyzed	43 participants
		43
Body Mass Index; Mean (Standard Deviation); Unit of measure: Kg/m^2
	Number Analyzed	43 participants
		26.3 (5.4)
Skin Pigmentation [1]; Mean (Standard Deviation); Unit of measure: Units on a scale
	Number Analyzed	43 participants
		1.84 (0.84)
		[1] Measure Description: Skin pigmentation was scored from 1 to 3 where 1 represents light skin pigmentation, 2 represents medium skin pigmentation, and 3 represents dark skin pigmentation.

Outcome Measures

1. Primary Outcome

Title	Normal Tissue Red Notification Rate
Description	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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Non-Infiltrated Tissue
Arm/Group Description:	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 Number of Participants Analyzed	40
Mean (95% Confidence Interval); Unit of Measure: red notifications per day
	0.24; (0.11 to 0.45)

2. Secondary Outcome

Title	Normal Tissue Yellow Notification Rate
Description	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

Outcome Measure Data

Analysis Population Description

Three participants were excluded due to significant protocol deviations.

Arm/Group Title	Non-Infiltrated Tissue
Arm/Group Description:	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 Number of Participants Analyzed	40
Mean (95% Confidence Interval); Unit of Measure: yellow notifications per day
	0.51; (0.31 to 0.79)

3. Secondary Outcome

Title	Significant Skin Irritation or Disruption to Skin Integrity
Description	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

Outcome Measure Data

Analysis Population Description

Three participants were excluded for significant protocol deviations.

Arm/Group Title	Non-Infiltrated Tissue
Arm/Group Description:	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 Number of Participants Analyzed	40
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: IV sites
	0; (0 to 0.0881)

Adverse Events

Time Frame	Adverse events were collected during the individual studies (approximately 24 hours)
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Non-Infiltrated Tissue
Arm/Group Description	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.
All-Cause Mortality
	Non-Infiltrated Tissue
	Affected / at Risk (%)
Total	--/--
Serious Adverse Events
	Non-Infiltrated Tissue
	Affected / at Risk (%)
Total	0/43 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	Non-Infiltrated Tissue
	Affected / at Risk (%)
Total	0/43 (0.00%)

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact

• Name/Title: Garret T. Bonnema
• Organization: ivWatch, LLC
• Phone: 1.855.489.2824 ext 7018
• EMail: garret.bonnema@ivwatch.com

• Responsible Party: Garret Bonnema, ivWatch, LLC
• ClinicalTrials.gov Identifier: NCT02120443
• Other Study ID Numbers: IVW400CS-05
• First Submitted: April 18, 2014
• First Posted: April 22, 2014
• Results First Submitted: April 22, 2014
• Results First Posted: June 23, 2014
• Last Update Posted: July 2, 2014