Trial Outcomes & Findings for Validation of a Novel Non-invasive Continuous Blood Pressure Monitor in Children Ages 2- 17 Years-old (NCT NCT04817137)
NCT ID: NCT04817137
Last Updated: 2026-07-23
Results Overview
The accuracy of blood pressure measurements (systolic) taken from the non-invasive blood pressure device will be compared to measurements taken from the patient's indwelling arterial line, which will be place as part of standard of care.
COMPLETED
NA
35 participants
One hour during procedure
2026-07-23
Participant Flow
Participant milestones
| Measure |
All Enrolled Patients
Patients will wear the Caretaker Pulse Decomposition Analysis (PDA) Device, which will record the patient's blood pressure.
CareTaker PDA Device: Non-invasive blood pressure monitoring
|
|---|---|
|
Overall Study
STARTED
|
35
|
|
Overall Study
COMPLETED
|
31
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
All Enrolled Patients
Patients will wear the Caretaker Pulse Decomposition Analysis (PDA) Device, which will record the patient's blood pressure.
CareTaker PDA Device: Non-invasive blood pressure monitoring
|
|---|---|
|
Overall Study
Case Cancelled
|
1
|
|
Overall Study
Change in Clinical Plan
|
3
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
All Enrolled Patients
n=31 Participants
Patients will wear the Caretaker Pulse Decomposition Analysis (PDA) Device, which will record the patient's blood pressure.
|
|---|---|
|
Age, Categorical
<=18 years
|
31 Participants
n=31 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=31 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=31 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=31 Participants
|
|
Region of Enrollment
United States
|
31 Participants
n=31 Participants
|
|
Weight
|
32.7 kg
STANDARD_DEVIATION 18.7 • n=31 Participants
|
PRIMARY outcome
Timeframe: One hour during procedureThe accuracy of blood pressure measurements (systolic) taken from the non-invasive blood pressure device will be compared to measurements taken from the patient's indwelling arterial line, which will be place as part of standard of care.
Outcome measures
| Measure |
All Enrolled Patients
n=31 Participants
Patients will wear the Caretaker Pulse Decomposition Analysis (PDA) Device, which will record the patient's blood pressure.
|
|---|---|
|
Blood Pressure Comparison (Systolic)
|
-3.79 mm Hg
Standard Deviation 9.74
|
PRIMARY outcome
Timeframe: One hour during procedureThe accuracy of blood pressure measurements (diastolic) taken from the non-invasive blood pressure device will be compared to measurements taken from the patient's indwelling arterial line, which will be place as part of standard of care.
Outcome measures
| Measure |
All Enrolled Patients
n=31 Participants
Patients will wear the Caretaker Pulse Decomposition Analysis (PDA) Device, which will record the patient's blood pressure.
|
|---|---|
|
Blood Pressure Comparison (Diastolic)
|
1.72 mm Hg
Standard Deviation 8.445
|
PRIMARY outcome
Timeframe: One hour during procedureThe accuracy of blood pressure measurements (mean) taken from the non-invasive blood pressure device will be compared to measurements taken from the patient's indwelling arterial line, which will be place as part of standard of care.
Outcome measures
| Measure |
All Enrolled Patients
n=31 Participants
Patients will wear the Caretaker Pulse Decomposition Analysis (PDA) Device, which will record the patient's blood pressure.
|
|---|---|
|
Blood Pressure Comparison (Mean)
|
2.41 mm Hg
Standard Deviation 8.57
|
Adverse Events
All Enrolled Patients
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