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

March 15, 2023 updated by: Sibel Health Inc.

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Comparison of ANNE One system blood pressure measurements to arterial line
Device: ANNE One
Chest sensor for single lead ECG and finger sensor for pulse oximetry.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean absolute error (MAE) and standard deviation of blood pressure measurements with ANNE One compared to arterial line
Time Frame: 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.
8 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sibel Health Inc.

Collaborators

University of North Carolina

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

May 1, 2023

Primary Completion (Anticipated)

December 31, 2023

Study Completion (Anticipated)

December 31, 2023

Study Registration Dates

First Submitted

March 15, 2023

First Submitted That Met QC Criteria

March 15, 2023

First Posted (Actual)

March 30, 2023

Study Record Updates

Last Update Posted (Actual)

March 30, 2023

Last Update Submitted That Met QC Criteria

March 15, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 22-2375

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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