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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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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.


Participant Flow:   Overall Study
    Infiltrated Tissue
STARTED   71 
COMPLETED   71 
NOT COMPLETED   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.


Baseline Measures
   Infiltrated Tissue 
Overall Participants Analyzed 
[Units: Participants]
 71 
Age 
[Units: Years]
Mean (Standard Deviation)
 38.2  (13.2) 
Age 
[Units: Participants]
 
<=18 years   1 
Between 18 and 65 years   69 
>=65 years   1 
Gender 
[Units: Participants]
 
Female   43 
Male   28 
Region of Enrollment 
[Units: Participants]
 
United States   71 
Body Mass Index 
[Units: Kg/m^2]
Mean (Standard Deviation)
 28.2  (6.61) 
Skin Pigmentation [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 1.704  (0.885) 
[1] 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.


  Outcome Measures

1.  Primary:   Red Notification Sensitivity to Infiltrated Tissues   [ Time Frame: After each participant has been infiltrated, an expected average of 1 hour ]

Measure Type Primary
Measure Title Red Notification Sensitivity to Infiltrated Tissues
Measure 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  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.


Measured Values
   Infiltrated Tissue 
Participants Analyzed   70 
Units Analyzed (Infiltrated IV sites)   140 
Red Notification Sensitivity to Infiltrated Tissues 
[Units: Percentage of infiltrations]
Number (95% Confidence Interval)
 96.4 
 (91.4 to 98.7) 

No statistical analysis provided for Red Notification Sensitivity to Infiltrated Tissues



2.  Secondary:   Yellow Notification Sensitivity to Infiltrated Tissues   [ Time Frame: After each participant has been infiltrated, an expected average of 1 hour ]

Measure Type Secondary
Measure Title Yellow Notification Sensitivity to Infiltrated Tissues
Measure 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  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.


Measured Values
   Infiltrated Tissue 
Participants Analyzed   70 
Units Analyzed (Infiltrated IV sites)   140 
Yellow Notification Sensitivity to Infiltrated Tissues 
[Units: Percentage of infiltrations]
Number (95% Confidence Interval)
 99.3 
 (95.5 to 99.96) 

No statistical analysis provided for Yellow Notification Sensitivity to Infiltrated Tissues



3.  Secondary:   Infiltrated Volume When Red Notification Issued   [ Time Frame: After each participant has been infiltrated, an expected average of 1 hour ]

Measure Type Secondary
Measure Title Infiltrated Volume When Red Notification Issued
Measure 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  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.


Measured Values
   Infiltrated Tissue 
Participants Analyzed   70 
Units Analyzed (Infiltrated IV sites)   140 
Infiltrated Volume When Red Notification Issued 
[Units: mL]
Mean (Standard Deviation)
 3.75  (2.13) 

No statistical analysis provided for Infiltrated Volume When Red Notification Issued



4.  Secondary:   Infiltrated Volume When Yellow Notification Issued   [ Time Frame: After each participant has been infiltrated, an expected average of 1 hour ]

Measure Type Secondary
Measure Title Infiltrated Volume When Yellow Notification Issued
Measure 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  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.


Measured Values
   Infiltrated Tissue 
Participants Analyzed   70 
Units Analyzed (Infiltrated IV sites)   140 
Infiltrated Volume When Yellow Notification Issued 
[Units: mL]
Mean (Standard Deviation)
 3.49  (2.04) 

No statistical analysis provided for Infiltrated Volume When Yellow Notification Issued



5.  Secondary:   Significant Skin Irritation or Disruption to Skin Integrity   [ Time Frame: After each participant has been infiltrated, an expected average of 1 hour ]

Measure Type Secondary
Measure Title Significant Skin Irritation or Disruption to Skin Integrity
Measure 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  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.


Measured Values
   Infiltrated Tissue 
Participants Analyzed   70 
Significant Skin Irritation or Disruption to Skin Integrity 
[Units: Participants]
 0 

No statistical analysis provided for Significant Skin Irritation or Disruption to Skin Integrity




  Serious Adverse Events

Time Frame No text entered.
Additional Description Serious and other (non-serious) adverse events were assessed by the clinician performing the study.

Reporting Groups
  Description
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.


Serious Adverse Events
    Infiltrated Tissue
Total, Serious Adverse Events   
# participants affected / at risk   0/71 (0.00%) 




  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

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
e-mail: garret.bonnema@ivwatch.com



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