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ivWatch Model 400: Device Validation for Infiltrated Tissues

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ClinicalTrials.gov Identifier: NCT02123745
Recruitment Status : Completed
First Posted : April 28, 2014
Results First Posted : June 27, 2014
Last Update Posted : June 27, 2014
Sponsor:
Information provided by (Responsible Party):
ivWatch, LLC

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Condition Infiltration of Peripheral IV Therapy
Intervention Device: The ivWatch Model 400
Enrollment 71

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Infiltrated Tissue
Hide Arm/Group Description

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.

Period Title: Overall Study
Started 71
Completed 71
Not Completed 0
Arm/Group Title Infiltrated Tissue
Hide Arm/Group Description

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 Number of Baseline Participants 71
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 71 participants
38.2  (13.2)
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 71 participants
<=18 years
1
   1.4%
Between 18 and 65 years
69
  97.2%
>=65 years
1
   1.4%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 71 participants
Female
43
  60.6%
Male
28
  39.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 71 participants
71
Body Mass Index  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 71 participants
28.2  (6.61)
Skin Pigmentation   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 71 participants
1.704  (0.885)
[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 Red Notification Sensitivity to Infiltrated Tissues
Hide Description 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.
Time Frame After each participant has been infiltrated, an expected average of 1 hour
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Infiltrated Tissue
Hide Arm/Group Description:

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 Number of Participants Analyzed 70
Overall Number of Units Analyzed
Type of Units Analyzed: Infiltrated IV sites
140
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of infiltrations
96.4
(91.4 to 98.7)
2.Secondary Outcome
Title Yellow Notification Sensitivity to Infiltrated Tissues
Hide Description 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.
Time Frame After each participant has been infiltrated, an expected average of 1 hour
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Infiltrated Tissue
Hide Arm/Group Description:

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 Number of Participants Analyzed 70
Overall Number of Units Analyzed
Type of Units Analyzed: Infiltrated IV sites
140
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of infiltrations
99.3
(95.5 to 99.96)
3.Secondary Outcome
Title Infiltrated Volume When Red Notification Issued
Hide Description The amount of infiltrated isotonic saline solution when the red notification was issued by the ivWatch Model 400 device.
Time Frame After each participant has been infiltrated, an expected average of 1 hour
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Infiltrated Tissue
Hide Arm/Group Description:

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 Number of Participants Analyzed 70
Overall Number of Units Analyzed
Type of Units Analyzed: Infiltrated IV sites
140
Mean (Standard Deviation)
Unit of Measure: mL
3.75  (2.13)
4.Secondary Outcome
Title Infiltrated Volume When Yellow Notification Issued
Hide Description The amount of infiltrated isotonic saline solution when the yellow notification was issued by the ivWatch Model 400 device.
Time Frame After each participant has been infiltrated, an expected average of 1 hour
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Infiltrated Tissue
Hide Arm/Group Description:

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 Number of Participants Analyzed 70
Overall Number of Units Analyzed
Type of Units Analyzed: Infiltrated IV sites
140
Mean (Standard Deviation)
Unit of Measure: mL
3.49  (2.04)
5.Secondary Outcome
Title Significant Skin Irritation or Disruption to Skin Integrity
Hide Description The number of IV sites that indicated significant skin irritation or disruption to skin integrity assessed at the end of the study.
Time Frame After each participant has been infiltrated, an expected average of 1 hour
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Infiltrated Tissue
Hide Arm/Group Description:

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 Number of Participants Analyzed 70
Measure Type: Number
Unit of Measure: participants
0
Time Frame [Not Specified]
Adverse Event Reporting Description Serious and other (non-serious) adverse events were assessed by the clinician performing the study.
 
Arm/Group Title Infiltrated Tissue
Hide Arm/Group Description

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.

All-Cause Mortality
Infiltrated Tissue
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Infiltrated Tissue
Affected / at Risk (%)
Total   0/71 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Infiltrated Tissue
Affected / at Risk (%)
Total   0/71 (0.00%) 
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
Responsible Party: ivWatch, LLC
ClinicalTrials.gov Identifier: NCT02123745     History of Changes
Other Study ID Numbers: IVW400CS-06
First Submitted: April 22, 2014
First Posted: April 28, 2014
Results First Submitted: April 28, 2014
Results First Posted: June 27, 2014
Last Update Posted: June 27, 2014