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

Sponsor

Sibel Health Inc. (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05790265

Collaborator

University of North Carolina (Other)

Enrollment

Arm

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Blood Pressure	Device: ANNE One	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Anticipated Study Start Date :

May 1, 2023

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Sibel Health Inc.
University of North Carolina

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Sibel Health Inc.

ClinicalTrials.gov Identifier:

NCT05790265

Other Study ID Numbers:

22-2375

First Posted:

Mar 30, 2023

Last Update Posted:

Mar 30, 2023

Last Verified:

Mar 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Study Results

No Results Posted as of Mar 30, 2023