Blood Pressure
Conditions
Brief summary
This study is a prospective study targeting at least 20 obese and super-obese patients admitted to Labor & Delivery (L&D) for delivery at UNC Medical Center. Patients with clinical indicated radial A-lines either planned or already in-situ will be offered participation. The study will evaluate the accuracy of noninvasive blood pressure measurements with the ANNE One system to blood pressure readings with the radial A-line.
Interventions
DEVICEANNE One
Chest sensor for single lead ECG and finger sensor for pulse oximetry.
Sponsors
University of North Carolina
Sibel Health Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age \>= 18 years old * Ability and willingness to provide written informed consent * Admitted for delivery at UNC Medical Center * BMI of \>= 40 kg/m2 * Clinically indicated radial A-lines either planned or already in-situ prior to delivery
Exclusion criteria
* Skin sensitivity or allergy that precludes placement of ANNE One * Any condition (social or medical) which, in the opinion of the study staff would make any study participation unsafe or complicate data interpretation * Expected delivery within \<= 1 hour of arrival to L&D
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean absolute error (MAE) and standard deviation of blood pressure measurements with ANNE One compared to arterial line | 8 hours | Mean absolute error and standard deviation between the non-invasive blood pressure measurement provided by the device under test and the invasive blood pressure measurement from the arterial line. |
Contacts
Primary ContactSarah E Coughlin
Outcome results
None listed