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ivWatch Model 400: Device Validation for Non-Infiltrated Tissues

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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:
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
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Non-Infiltrated Tissue
Hide 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
Arm/Group Title Non-Infiltrated Tissue
Hide 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
Hide 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.
1.Primary Outcome
Title Normal Tissue Red Notification Rate
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Three subjects were excluded from analysis due to significant protocol deviations.
Arm/Group Title Non-Infiltrated Tissue
Hide 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Three participants were excluded due to significant protocol deviations.
Arm/Group Title Non-Infiltrated Tissue
Hide 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Three participants were excluded for significant protocol deviations.
Arm/Group Title Non-Infiltrated Tissue
Hide 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)
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
Hide 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   --/-- 
Hide Serious Adverse Events
Non-Infiltrated Tissue
Affected / at Risk (%)
Total   0/43 (0.00%) 
Hide 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%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Garret T. Bonnema
Organization: ivWatch, LLC
Phone: 1.855.489.2824 ext 7018
EMail: garret.bonnema@ivwatch.com
Layout table for additonal information
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