Trials / Completed
CompletedNCT04817137
Validation of a Novel Non-invasive Continuous Blood Pressure Monitor in Children Ages 2- 17 Years-old
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 35 (actual)
- Sponsor
- Boston Children's Hospital · Academic / Other
- Sex
- All
- Age
- 2 Years – 17 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | CareTaker PDA Device | Non-invasive blood pressure monitoring |
Timeline
- Start date
- 2021-05-14
- Primary completion
- 2023-07-21
- Completion
- 2023-07-21
- First posted
- 2021-03-26
- Last updated
- 2026-04-09
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04817137. Inclusion in this directory is not an endorsement.