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A single arm trial consisting of 70 adult volunteers to assess the safety and efficacy of the ivWatch Model 400 when observing infiltrated tissues at common sites for peripheral IV therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Infiltrated Tissue | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| The ivWatch Model 400 | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | After each participant has been infiltrated, an expected average of 1 hour |
| Measure | Description | Time Frame |
|---|---|---|
| Yellow Notification Sensitivity to Infiltrated Tissues | 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. | After each participant has been infiltrated, an expected average of 1 hour |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ivWatch, LLC | Williamsburg | Virginia | 23185 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Number | 95% Confidence Interval | percentage of infiltrations | After each participant has been infiltrated, an expected average of 1 hour | infiltrated IV sites | Participants |
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Serious and other (non-serious) adverse events were assessed by the clinician performing the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Garret T. Bonnema | ivWatch, LLC | 1.855.489.2824 | 7018 | garret.bonnema@ivwatch.com |
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| Infiltrated Volume When Red Notification Issued | The amount of infiltrated isotonic saline solution when the red notification was issued by the ivWatch Model 400 device. | After each participant has been infiltrated, an expected average of 1 hour |
| Infiltrated Volume When Yellow Notification Issued | The amount of infiltrated isotonic saline solution when the yellow notification was issued by the ivWatch Model 400 device. | After each participant has been infiltrated, an expected average of 1 hour |
| Significant Skin Irritation or Disruption to Skin Integrity | The number of IV sites that indicated significant skin irritation or disruption to skin integrity assessed at the end of the study. | After each participant has been infiltrated, an expected average of 1 hour |
| years |
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| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Body Mass Index | Mean | Standard Deviation | kg/m^2 |
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| Skin Pigmentation | 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. | Mean | Standard Deviation | units on a scale |
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| Secondary | Yellow Notification Sensitivity to Infiltrated Tissues | 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. | Posted | Number | 95% Confidence Interval | percentage of infiltrations | After each participant has been infiltrated, an expected average of 1 hour | infiltrated IV sites | Participants |
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| Secondary | Infiltrated Volume When Red Notification Issued | The amount of infiltrated isotonic saline solution when the red notification was issued by the ivWatch Model 400 device. | Posted | Mean | Standard Deviation | mL | After each participant has been infiltrated, an expected average of 1 hour | infiltrated IV sites | Participants |
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| Secondary | Infiltrated Volume When Yellow Notification Issued | The amount of infiltrated isotonic saline solution when the yellow notification was issued by the ivWatch Model 400 device. | Posted | Mean | Standard Deviation | mL | After each participant has been infiltrated, an expected average of 1 hour | infiltrated IV sites | Participants |
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| Secondary | Significant Skin Irritation or Disruption to Skin Integrity | The number of IV sites that indicated significant skin irritation or disruption to skin integrity assessed at the end of the study. | Posted | Number | participants | After each participant has been infiltrated, an expected average of 1 hour |
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| 71 |
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| 71 |
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