Blood Pressure
Conditions
Brief summary
This is a prospective observational study to investigate if a non-invasive blood pressure monitoring device, the CareTaker Pulse Decomposition Analysis (PDA), can accurately measure blood pressure in children when compared to an arterial line. Enrolled patients will have the CareTaker PDA device placed on their finger during their operation to collect data for 30 minutes. Blood pressure readings from the CareTaker PDA device will be compared to measurements from the patient's indwelling arterial line, which will be placed as part of the patient's clinical care plan.
Interventions
DEVICECareTaker PDA Device
Non-invasive blood pressure monitoring
Sponsors
Boston Children's Hospital
CareTaker Medical LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* Plan to receive an invasive arterial blood pressure monitor as part of their anesthesia care plan at the BCH Longwood campus
Exclusion criteria
* Patients with vascular or congenital heart disease known to affect large and small arteries * Patients who declined to participate.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Blood Pressure Comparison (Systolic) | One hour during procedure | 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. |
| Blood Pressure Comparison (Diastolic) | One hour during procedure | The 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. |
| Blood Pressure Comparison (Mean) | One hour during procedure | The 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORKaren Boretsky, MD
Boston Children's Hospital
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 31 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Region of Enrollment United States | 31 Participants |
| Sex: Female, Male Female | 20 Participants |
| Sex: Female, Male Male | 11 Participants |
| Weight | 32.7 kg STANDARD_DEVIATION 18.7 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 31 |
| other Total, other adverse events | 0 / 31 |
| serious Total, serious adverse events | 0 / 31 |
Outcome results
None listed