An interventional study of The ivWatch Model 400 in Infiltration of Peripheral IV Therapy, sponsored by ivWatch, LLC. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-06-27.
Sponsored by ivWatch, LLC · Not applicable, Interventional, and Diagnostic
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.
ivWatch, LLC is the lead sponsor of 9 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Device: 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
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
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.
Time frame: After each participant has been infiltrated, an expected average of 1 hour
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.
Time frame: 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.
Time frame: 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.
Time frame: After each participant has been infiltrated, an expected average of 1 hour
| Milestone | Infiltrated Tissue |
|---|---|
| Started | 71 |
| Completed | 71 |
| Not completed | 0 |
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.
| percentage of infiltrations | Infiltrated Tissue |
|---|---|
| Red Notification Sensitivity to Infiltrated Tissues | 96.4 (91.4 to 98.7) |
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.
| percentage of infiltrations | Infiltrated Tissue |
|---|---|
| Yellow Notification Sensitivity to Infiltrated Tissues | 99.3 (95.5 to 99.96) |
The amount of infiltrated isotonic saline solution when the red notification was issued by the ivWatch Model 400 device.
| mL | Infiltrated Tissue |
|---|---|
| Infiltrated Volume When Red Notification Issued | 3.75 ± 2.13 |
The amount of infiltrated isotonic saline solution when the yellow notification was issued by the ivWatch Model 400 device.
| mL | Infiltrated Tissue |
|---|---|
| Infiltrated Volume When Yellow Notification Issued | 3.49 ± 2.04 |
The number of IV sites that indicated significant skin irritation or disruption to skin integrity assessed at the end of the study.
| participants | Infiltrated Tissue |
|---|---|
| Significant Skin Irritation or Disruption to Skin Integrity | 0 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Infiltrated Tissue | — | 0/71 (0%) | 0/71 (0%) |
| Age, Continuous(years) | Infiltrated Tissue |
|---|---|
| Mean | 38.2 ± 13.2 |
| Age, Categorical(Participants) | Infiltrated Tissue |
|---|---|
| <=18 years | 1 |
| Between 18 and 65 years | 69 |
| >=65 years | 1 |
| Sex: Female, Male(Participants) | Infiltrated Tissue |
|---|---|
| Female | 43 |
| Male | 28 |
| Region of Enrollment(participants) | Infiltrated Tissue |
|---|---|
| United States | 71 |
| Body Mass Index(kg/m^2) | Infiltrated Tissue |
|---|---|
| Mean | 28.2 ± 6.61 |
| Skin Pigmentation(units on a scale) | Infiltrated Tissue |
|---|---|
| Mean | 1.704 ± 0.885 |
This study is completed, as verified in May 2014. You cannot join it, but the record below documents what was studied.
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