UnknownNot Applicable

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

20 participantsStarted 2023-05-01

Plain-language 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.

Who can participate

Age range18 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Mean absolute error (MAE) and standard deviation of blood pressure measurements with ANNE One compared to arterial line

Timeframe: 8 hours

Trial details

NCT IDNCT05790265

SponsorSibel Health Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-12-31

Contact for this trial

Sarah E Coughlin

(224)251-8859 sarah.coughlin@sibelhealth.com

View on ClinicalTrials.gov More Blood Pressure trials