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

NCT ID: NCT05790265

Last Updated: 2023-03-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-01

Study Completion Date

2023-12-31

Brief Summary

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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

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Conditions

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Blood Pressure

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Comparison of ANNE One system blood pressure measurements to arterial line

Group Type EXPERIMENTAL

ANNE One

Intervention Type DEVICE

Chest sensor for single lead ECG and finger sensor for pulse oximetry.

Interventions

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ANNE One

Chest sensor for single lead ECG and finger sensor for pulse oximetry.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of North Carolina

OTHER

Sponsor Role collaborator

Sibel Health Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Sarah E Coughlin

Role: CONTACT

(224)251-8859

Other Identifiers

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22-2375

Identifier Type: -

Identifier Source: org_study_id

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