Assessing Innovative Wireless and Wearable Sensors for Continuous Blood Pressure Measurement in Obese Pregnant Women

Sibel Health

Status: Not yet enrolling

Conditions: Blood Pressure

Treatments: Device: ANNE One

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05790265

22-2375

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Comparison of ANNE One system blood pressure measurements to arterial line

Experimental group

Treatment:

Device: ANNE One