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

Blood Pressure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05790265
• Other study ID #: 22-2375
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 1, 2023
• Est. completion date: December 31, 2023

Study information

• Verified date: March 2023
• Source: Sibel Health Inc.
• Contact: Sarah E Coughlin
• Phone: (224)251-8859
• Email: sarah.coughlin[@]sibelhealth.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Blood Pressure

Intervention

Device:
• ANNE One
Chest sensor for single lead ECG and finger sensor for pulse oximetry.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Sibel Health Inc.	University of North Carolina

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean absolute error (MAE) and standard deviation of blood pressure measurements with ANNE One compared to arterial line	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