ivWatch Sensor: Device Validation for Infiltrated Tissues

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04064229

Enrollment

Registered

2019-08-21

Start date

2019-04-03

Completion date

2019-04-09

Last updated

2022-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infiltration of Peripheral IV Therapy

Brief summary

A single arm trial consisting of 98 adult volunteers to assess the safety and efficacy of ivWatch sensors when observing infiltrated tissues at common sites for peripheral IV therapy.

Interventions

DEVICEivWatch Model 400 with SmartTouch Sensor

The ivWatch Model 400 with SmartTouch Sensor monitored the site during the course of the infiltration and issued red and/or yellow notifications if an infiltration was detected.

DEVICEivWatch Model 400 with Fiber Optic Sensor

The ivWatch Model 400 with Fiber Optic Sensor monitored the site during the course of the infiltration and issued red and/or yellow notifications if an infiltration was detected.

Study design

Allocation

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 by clinician * 18 years or older

Exclusion criteria

* Fail health screen

Design outcomes

Primary

Measure	Time frame	Description
Red Notification Sensitivity to Infiltrated Tissues	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.

Secondary

Measure	Time frame	Description
Yellow Notification Sensitivity to Infiltrated Tissues	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.
Infiltrated Volume When Red Notification Issued	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.
Infiltrated Volume When Yellow Notification Issued	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.
Significant Skin Irritation or Disruption to Skin Integrity	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.

Countries

United States

Participant flow

Participants by arm

Arm	Count
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.	98
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.	196
Total	294

Baseline characteristics

Characteristic	Infiltrated Tissue
Age, Categorical <=18 years	0 Participants
Age, Categorical >=65 years	6 Participants
Age, Categorical Between 18 and 65 years	92 Participants
Age, Continuous	41.1 years STANDARD_DEVIATION 15.5
Body Mass Index (BMI) Normal (BMI 18.5 to < 25)	22 Participants
Body Mass Index (BMI) Obese (BMI >= 30)	47 Participants
Body Mass Index (BMI) Overweight (BMI 25 to < 30)	29 Participants
Sex: Female, Male Female	62 Participants
Sex: Female, Male Male	36 Participants
Skin Pigmentation	1.76 units on a scale STANDARD_DEVIATION 0.84

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 99	0 / 99
other Total, other adverse events	0 / 99	0 / 99
serious Total, serious adverse events	0 / 99	0 / 99

Outcome results

Primary

Red Notification Sensitivity to Infiltrated Tissues

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.