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

Not Applicable

Not yet recruiting

• Conditions: Blood Pressure
• Interventions: Device: ANNE One

• Registration Number: NCT05790265
• Lead Sponsor: Sibel Health Inc.

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-03
• Study First Submitted: 2023-03-15
• Study First Submitted QC: 2023-03-15
• Last Update Submitted: 2023-03-15
• Study First Posted: 2023-03-30
• Last Update Posted: 2023-03-30
• Study Start: 2023-05-01
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Comparison of ANNE One system blood pressure measurements to arterial line	ANNE One	-

Primary Outcome Measures

Name	Time	Method
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.