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This study will examine the use of the ivWatch Model 400 to monitor PIV sites in pediatric patients. Half the participants will be monitored by the device without infiltration notifications and the other half will be monitored by the device with infiltration notifications enabled.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pilot | Experimental | A non-alarming ivWatch device will monitor the IV sites of these subjects. The goal of this small pilot study is to give clinicians an opportunity to perform the protocol and operate the ivWatch device and to give researchers the ability to make adjustments prior to starting the subsequent non-alarming group. |
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| Non-alarming | Experimental | 150 patients will be enrolled in the non-alarming group. The ivWatch device will monitor the IV sites but will not issue infiltration notifications. |
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| Alarming | Experimental | 150 patients will be enrolled in the alarming group. The IV sites will be monitored with the ivWatch Model 400 infiltration notifications enabled. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ivWatch Model 400 | Device | The ivWatch Model 400 is placed next to the subject's PIV site. All subjects will receive standard care for their IV sites including the normal routine assessments of the IV site by the bedside registered nurses. |
| Measure | Description | Time Frame |
|---|---|---|
| Time Infiltration Detected by Nurse | The difference in time to detection between the clinician and the ivWatch device is measured from the non-alarming group. This measurement reveals how much earlier the infiltration could have been detected by the ivWatch device compared to the clinician assessments. This metric is measured using the patients in the non-alarming group since an infiltration notification by the ivWatch device could bias the clinician's diagnosis. | Participants will be followed for the duration of intravenous therapy, an expected duration of up to 1 week |
| Infiltration Sensitivity | The infiltration sensitivity is defined as the percentage of the clinician-confirmed infiltrations that are detected by the ivWatch device before the clinician's diagnosis. This metric is measured and reported separately for non-alarming and alarming groups, since an infiltration notification by the ivWatch device could bias the clinician's diagnosis. | Participants will be followed for the duration of intravenous therapy, an expected duration of up to 1 week |
| Notification Rate of ivWatch Device | The notification rate is defined as the number of ivWatch device infiltration notifications issued in a certain amount of time, typically reported in units of notifications per day. The notification rate is the number of notifications per day, excluding cases with clinician confirmed infiltrations. This metric is measured using the subjects in the alarming group since the number of notifications could potentially depend on how quickly nurses reset the device. | Participants will be followed for the duration of intravenous therapy, an expected duration of up to 1 week |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Non-alarming | The ivWatch device will monitor the IV sites but will not issue infiltration notifications. ivWatch Model 400: The ivWatch Model 400 is placed next to the subject's PIV site. All subjects will receive standard care for their IV sites including the normal routine assessments of the IV site by the bedside registered nurses. Patients enrolled into the pilot and non-alarming portion of the study were combined for analysis due to no protocol changes between the study arms. |
| FG001 | Alarming | The IV sites will be monitored with the ivWatch Model 400 infiltration notifications enabled. ivWatch Model 400: The ivWatch Model 400 is placed next to the subject's PIV site. All subjects will receive standard care for their IV sites including the normal routine assessments of the IV site by the bedside registered nurses. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Non-alarming | The ivWatch device will monitor the IV sites but will not issue infiltration notifications. ivWatch Model 400: The ivWatch Model 400 is placed next to the subject's PIV site. All subjects will receive standard care for their IV sites including the normal routine assessments of the IV site by the bedside registered nurses. Patients enrolled into the pilot and non-alarming portion of the study were combined for analysis due to no protocol changes between the study arms. |
| 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 | Time Infiltration Detected by Nurse | The difference in time to detection between the clinician and the ivWatch device is measured from the non-alarming group. This measurement reveals how much earlier the infiltration could have been detected by the ivWatch device compared to the clinician assessments. This metric is measured using the patients in the non-alarming group since an infiltration notification by the ivWatch device could bias the clinician's diagnosis. | Posted | Mean | 95% Confidence Interval | hours | Participants will be followed for the duration of intravenous therapy, an expected duration of up to 1 week |
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Participants will be followed for the duration of intravenous therapy, an expected duration of up to 1 week
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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 | Non-alarming | The ivWatch device will monitor the IV sites but will not issue infiltration notifications. ivWatch Model 400: The ivWatch Model 400 is placed next to the subject's PIV site. All subjects will receive standard care for their IV sites including the normal routine assessments of the IV site by the bedside registered nurses. Patients enrolled into the pilot and non-alarming portion of the study were combined for analysis due to no protocol changes between the study arms. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jason Naramore | ivWatch, LLC | 855-485-2824 | 7019 | jason.naramore@ivwatch.com |
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| Improper Device Placement |
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| BG001 | Alarming | The IV sites will be monitored with the ivWatch Model 400 infiltration notifications enabled. ivWatch Model 400: The ivWatch Model 400 is placed next to the subject's PIV site. All subjects will receive standard care for their IV sites including the normal routine assessments of the IV site by the bedside registered nurses. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| IV Site | Number | participants |
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| Primary | Infiltration Sensitivity | The infiltration sensitivity is defined as the percentage of the clinician-confirmed infiltrations that are detected by the ivWatch device before the clinician's diagnosis. This metric is measured and reported separately for non-alarming and alarming groups, since an infiltration notification by the ivWatch device could bias the clinician's diagnosis. | Posted | Number | 95% Confidence Interval | percentage of infiltrations detected | Participants will be followed for the duration of intravenous therapy, an expected duration of up to 1 week |
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| Primary | Notification Rate of ivWatch Device | The notification rate is defined as the number of ivWatch device infiltration notifications issued in a certain amount of time, typically reported in units of notifications per day. The notification rate is the number of notifications per day, excluding cases with clinician confirmed infiltrations. This metric is measured using the subjects in the alarming group since the number of notifications could potentially depend on how quickly nurses reset the device. | The number of participated in the Alarming group that did not have an infiltration diagnosed by a clinician. | Posted | Number | 95% Confidence Interval | Notifications per day | Participants will be followed for the duration of intravenous therapy, an expected duration of up to 1 week |
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| 0 |
| 185 |
| 0 |
| 185 |
| EG001 | Alarming | The IV sites will be monitored with the ivWatch Model 400 infiltration notifications enabled. ivWatch Model 400: The ivWatch Model 400 is placed next to the subject's PIV site. All subjects will receive standard care for their IV sites including the normal routine assessments of the IV site by the bedside registered nurses. | 0 | 58 | 0 | 58 |
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