NCT05790265

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2023

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 15, 2023

Completed
15 days until next milestone

First Posted

Study publicly available on registry

March 30, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

May 1, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

March 30, 2023

Status Verified

March 1, 2023

Enrollment Period

8 months

First QC Date

March 15, 2023

Last Update Submit

March 15, 2023

Conditions

Blood Pressure

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Comparison of ANNE One system blood pressure measurements to arterial line

EXPERIMENTAL
Device: ANNE One

Interventions

ANNE OneDEVICE

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

Comparison of ANNE One system blood pressure measurements to arterial line

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

Sarah E Coughlin

CONTACT

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 15, 2023

First Posted

March 30, 2023

Study Start

May 1, 2023

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

March 30, 2023

Record last verified: 2023-03