Trial Outcomes & Findings for ivWatch Model 400: Device Validation for Infiltrated Tissues (NCT NCT02123745)

NCT ID: NCT02123745

Last Updated: 2014-06-27

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

71 participants

Primary outcome timeframe

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

Results posted on

2014-06-27

Participant Flow

Participant milestones

Participant milestones
Measure	Infiltrated Tissue The ivWatch Model 400 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. The 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	71
Overall Study COMPLETED	71
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

ivWatch Model 400: Device Validation for Infiltrated Tissues

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Infiltrated Tissue n=71 Participants The ivWatch Model 400 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. The 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, Continuous	38.2 years STANDARD_DEVIATION 13.2 • n=5 Participants
Age, Categorical <=18 years	1 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	69 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Sex: Female, Male Female	43 Participants n=5 Participants
Sex: Female, Male Male	28 Participants n=5 Participants
Region of Enrollment United States	71 participants n=5 Participants
Body Mass Index	28.2 kg/m^2 STANDARD_DEVIATION 6.61 • n=5 Participants
Skin Pigmentation	1.704 units on a scale STANDARD_DEVIATION 0.885 • n=5 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	Infiltrated Tissue n=140 infiltrated IV sites The ivWatch Model 400 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. The 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.
Red Notification Sensitivity to Infiltrated Tissues	96.4 percentage of infiltrations Interval 91.4 to 98.7

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	Infiltrated Tissue n=140 infiltrated IV sites The ivWatch Model 400 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. The 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.
Yellow Notification Sensitivity to Infiltrated Tissues	99.3 percentage of infiltrations Interval 95.5 to 99.96

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	Infiltrated Tissue n=140 infiltrated IV sites The ivWatch Model 400 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. The 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.
Infiltrated Volume When Red Notification Issued	3.75 mL Standard Deviation 2.13

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	Infiltrated Tissue n=140 infiltrated IV sites The ivWatch Model 400 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. The 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.
Infiltrated Volume When Yellow Notification Issued	3.49 mL Standard Deviation 2.04

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	Infiltrated Tissue n=70 Participants The ivWatch Model 400 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. The 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.
Significant Skin Irritation or Disruption to Skin Integrity	0 participants

Adverse Events

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