Infiltration of Peripheral IV Therapy
Conditions
Keywords
infiltration, extravasation, peripheral intravenous therapy
Brief summary
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.
Interventions
DEVICEivWatch 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.
Sponsors
ivWatch, LLC
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 17 Years
Healthy volunteers
No
Inclusion criteria
* Signed consent and/or assent * Newborn to 17 years of age * Weight \> 2.5 kg
Exclusion criteria
* Severe skin integrity issues such as severe eczema, burns, epidermolysis bullosa, rash, hives * Severe scarring of tissue (excessive IV use) * Tattoo in area of PIV site * IV site located in antecubital fossa
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time Infiltration Detected by Nurse | Participants will be followed for the duration of intravenous therapy, an expected duration of up to 1 week | 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. |
| Infiltration Sensitivity | Participants will be followed for the duration of intravenous therapy, an expected duration of up to 1 week | 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. |
| Notification Rate of ivWatch Device | Participants will be followed for the duration of intravenous therapy, an expected duration of up to 1 week | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 185 |
| 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. | 58 |
| Total | 243 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Improper Device Placement | 3 | 0 |
| Overall Study | Incomplete or Insufficient Data Collecte | 5 | 0 |
| Overall Study | Lost to Follow-up | 21 | 1 |
Baseline characteristics
| Characteristic | Non-alarming | Alarming | Total |
|---|---|---|---|
| Age, Continuous | 7.61 years | 7.19 years | 7.51 years |
| IV Site Forearm | 81 participants | 32 participants | 113 participants |
| IV Site Hand | 88 participants | 26 participants | 114 participants |
| IV Site Leg/Foot | 12 participants | 0 participants | 12 participants |
| IV Site Other | 4 participants | 0 participants | 4 participants |
| Sex: Female, Male Female | 95 Participants | 32 Participants | 127 Participants |
| Sex: Female, Male Male | 90 Participants | 26 Participants | 116 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 185 | 0 / 58 |
| serious Total, serious adverse events | 0 / 185 | 0 / 58 |
Outcome results
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.
Time frame: Participants will be followed for the duration of intravenous therapy, an expected duration of up to 1 week
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Non-alarming | Infiltration Sensitivity | 78.3 percentage of infiltrations detected |
| Alarming | Infiltration Sensitivity | 80 percentage of infiltrations detected |
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.
Time frame: Participants will be followed for the duration of intravenous therapy, an expected duration of up to 1 week
Population: The number of participated in the Alarming group that did not have an infiltration diagnosed by a clinician.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Non-alarming | Notification Rate of ivWatch Device | Red Notifications | 0.280 Notifications per day |
| Non-alarming | Notification Rate of ivWatch Device | Yellow Notifications | 0.274 Notifications per day |
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.
Time frame: Participants will be followed for the duration of intravenous therapy, an expected duration of up to 1 week
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Non-alarming | Time Infiltration Detected by Nurse | Red Notification | 29.8 hours |
| Non-alarming | Time Infiltration Detected by Nurse | Yellow Notification | 32.3 hours |