Trial Outcomes & Findings for Optical Detection of Intravenous Infiltration:A Pilot Study (NCT NCT02553421)
NCT ID: NCT02553421
Last Updated: 2017-04-06
Results Overview
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.
COMPLETED
NA
243 participants
Participants will be followed for the duration of intravenous therapy, an expected duration of up to 1 week
2017-04-06
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
185
|
58
|
|
Overall Study
COMPLETED
|
156
|
57
|
|
Overall Study
NOT COMPLETED
|
29
|
1
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
21
|
1
|
|
Overall Study
Incomplete or Insufficient Data Collecte
|
5
|
0
|
|
Overall Study
Improper Device Placement
|
3
|
0
|
Baseline Characteristics
Optical Detection of Intravenous Infiltration:A Pilot Study
Baseline characteristics by cohort
| Measure |
Non-alarming
n=185 Participants
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.
|
Alarming
n=58 Participants
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.
|
Total
n=243 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
7.61 years
n=5 Participants
|
7.19 years
n=7 Participants
|
7.51 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
95 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
127 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
90 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
116 Participants
n=5 Participants
|
|
IV Site
Hand
|
88 participants
n=5 Participants
|
26 participants
n=7 Participants
|
114 participants
n=5 Participants
|
|
IV Site
Forearm
|
81 participants
n=5 Participants
|
32 participants
n=7 Participants
|
113 participants
n=5 Participants
|
|
IV Site
Leg/Foot
|
12 participants
n=5 Participants
|
0 participants
n=7 Participants
|
12 participants
n=5 Participants
|
|
IV Site
Other
|
4 participants
n=5 Participants
|
0 participants
n=7 Participants
|
4 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Participants will be followed for the duration of intravenous therapy, an expected duration of up to 1 weekThe 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.
Outcome measures
| Measure |
Non-alarming
n=156 Participants
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.
|
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.
|
|---|---|---|
|
Time Infiltration Detected by Nurse
Red Notification
|
29.8 hours
Interval 14.8 to 44.8
|
—
|
|
Time Infiltration Detected by Nurse
Yellow Notification
|
32.3 hours
Interval 17.3 to 47.3
|
—
|
PRIMARY outcome
Timeframe: Participants will be followed for the duration of intravenous therapy, an expected duration of up to 1 weekThe 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.
Outcome measures
| Measure |
Non-alarming
n=156 Participants
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.
|
Alarming
n=57 Participants
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.
|
|---|---|---|
|
Infiltration Sensitivity
|
78.3 percentage of infiltrations detected
Interval 56.5 to 92.5
|
80 percentage of infiltrations detected
Interval 51.9 to 95.7
|
PRIMARY outcome
Timeframe: Participants will be followed for the duration of intravenous therapy, an expected duration of up to 1 weekPopulation: The number of participated in the Alarming group that did not have an infiltration diagnosed by a clinician.
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.
Outcome measures
| Measure |
Non-alarming
n=42 Participants
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.
|
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.
|
|---|---|---|
|
Notification Rate of ivWatch Device
Red Notifications
|
0.280 Notifications per day
Interval 0.156 to 0.5
|
—
|
|
Notification Rate of ivWatch Device
Yellow Notifications
|
0.274 Notifications per day
Interval 0.119 to 0.631
|
—
|
Adverse Events
Non-alarming
Alarming
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60