Trial Outcomes & Findings for ivWatch Sensor: Device Validation for Infiltrated Tissues (NCT NCT04064229)

NCT ID: NCT04064229

Last Updated: 2022-06-24

Results Overview

The ratio of the number of infiltrated IV sites where the ivWatch Model 400 device issued a red notification to the total number of infiltrated IV sites in the study. All infiltrations were limited to 10 mL of isotonic saline solution.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

99 participants

Primary outcome timeframe

After each participant has been infiltrated, an expected average of 1 hour

Results posted on

2022-06-24

Participant Flow

Unit of analysis: IV site

Participant milestones

Participant milestones
Measure	Infiltrated Tissue The ivWatch Model 400 sensors monitored an IV site during the infiltration of 10 mL of isotonic saline solution. IV sites were placed in the forearm and the dorsal aspect of the hand. The rate of the infiltration ranged between 5 mL/hr to 150 mL/hr. ivWatch Model 400: The ivWatch Model 400 monitored the site during the course of the infiltration and issued red and/or yellow notifications if an infiltration was detected.
Overall Study STARTED	99 198
Overall Study COMPLETED	99 198
Overall Study NOT COMPLETED	0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

ivWatch Sensor: Device Validation for Infiltrated Tissues

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Infiltrated Tissue n=196 IV Site The ivWatch Model 400 sensors monitored an IV site during the infiltration of 10 mL of isotonic saline solution. IV sites were placed in the forearm and the dorsal aspect of the hand. The rate of the infiltration ranged between 5 mL/hr to 150 mL/hr. ivWatch Model 400: The ivWatch Model 400 monitored the site during the course of the infiltration and issued red and/or yellow notifications if an infiltration was detected.
Age, Categorical <=18 years	0 Participants n=98 Participants
Age, Categorical Between 18 and 65 years	92 Participants n=98 Participants
Age, Categorical >=65 years	6 Participants n=98 Participants
Age, Continuous	41.1 years STANDARD_DEVIATION 15.5 • n=98 Participants
Sex: Female, Male Female	62 Participants n=98 Participants
Sex: Female, Male Male	36 Participants n=98 Participants
Skin Pigmentation	1.76 units on a scale STANDARD_DEVIATION 0.84 • n=98 Participants
Body Mass Index (BMI) Normal (BMI 18.5 to < 25)	22 Participants n=98 Participants
Body Mass Index (BMI) Overweight (BMI 25 to < 30)	29 Participants n=98 Participants
Body Mass Index (BMI) Obese (BMI >= 30)	47 Participants n=98 Participants

PRIMARY outcome

Timeframe: After each participant has been infiltrated, an expected average of 1 hour

The ratio of the number of infiltrated IV sites where the ivWatch Model 400 device issued a red notification to the total number of infiltrated IV sites in the study. All infiltrations were limited to 10 mL of isotonic saline solution.

Outcome measures

Outcome measures
Measure	SmartTouch Sensor n=98 IV Site ivWatch Model 400 with SmartTouch sensor used to monitor IV site	Fiber Optic Sensor n=98 IV Site ivWatch Model 400 with Fiber Optic sensor used to monitor IV site
Red Notification Sensitivity to Infiltrated Tissues	99.0 percentage of infiltrations detected Interval 94.5 to 100.0	99.0 percentage of infiltrations detected Interval 94.5 to 100.0

SECONDARY outcome

Timeframe: After each participant has been infiltrated, an expected average of 1 hour

The ratio of the number of infiltrated IV sites where the ivWatch Model 400 device issued a yellow notification to the total number of infiltrated IV sites in the study. All infiltrations were limited to 10 mL of isotonic saline solution.

Outcome measures

Outcome measures
Measure	SmartTouch Sensor n=98 IV SIte ivWatch Model 400 with SmartTouch sensor used to monitor IV site	Fiber Optic Sensor n=98 IV SIte ivWatch Model 400 with Fiber Optic sensor used to monitor IV site
Yellow Notification Sensitivity to Infiltrated Tissues	99.0 percentage of infiltrations detected Interval 94.5 to 100.0	99.0 percentage of infiltrations detected Interval 94.5 to 100.0

SECONDARY outcome

Timeframe: After each participant has been infiltrated, an expected average of 1 hour

The amount of infiltrated isotonic saline solution when the red notification was issued by the ivWatch Model 400 device.

Outcome measures

Outcome measures
Measure	SmartTouch Sensor n=98 IV Site ivWatch Model 400 with SmartTouch sensor used to monitor IV site	Fiber Optic Sensor n=98 IV Site ivWatch Model 400 with Fiber Optic sensor used to monitor IV site
Infiltrated Volume When Red Notification Issued	1.75 mL Standard Deviation 1.45	4.33 mL Standard Deviation 2.11

SECONDARY outcome

Timeframe: After each participant has been infiltrated, an expected average of 1 hour

The amount of infiltrated isotonic saline solution when the yellow notification was issued by the ivWatch Model 400 device.

Outcome measures

Outcome measures
Measure	SmartTouch Sensor n=98 IV Site ivWatch Model 400 with SmartTouch sensor used to monitor IV site	Fiber Optic Sensor n=98 IV Site ivWatch Model 400 with Fiber Optic sensor used to monitor IV site
Infiltrated Volume When Yellow Notification Issued	1.66 mL Standard Deviation 1.39	3.90 mL Standard Deviation 1.89

SECONDARY outcome

Timeframe: After each participant has been infiltrated, an expected average of 1 hour

The number of IV sites that indicated significant skin irritation or disruption to skin integrity assessed at the end of the study.

Outcome measures

Outcome measures
Measure	SmartTouch Sensor n=98 IV Site ivWatch Model 400 with SmartTouch sensor used to monitor IV site	Fiber Optic Sensor n=98 IV Site ivWatch Model 400 with Fiber Optic sensor used to monitor IV site
Significant Skin Irritation or Disruption to Skin Integrity	0 IV Site	0 IV Site

Adverse Events

SmartTouch Sensor

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Fiber Optic Sensor

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

Jason Naramore

ivWatch, LLC

Phone: 1-855-489-2824

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place