Recruiting

Observational Study

Sponsor:

GE Healthcare

Code:

NCT05789849

Conditions

Blood Pressure

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Collecting blood pressure measurements with noninvasive blood pressure device

Study Details

Brief summary:

The purpose of the study is to collect per subject blood pressure data on the device's intended population as described in the International Organization for Standardization (ISO) Standard 81060-2:2018+A1:2020 Non-invasive sphygmomanometers.

Conditions

Blood Pressure

Study ID

NCT05789849

Start date

Sep 14, 2022

Status verified date

Mar, 2023

Completion date

Sep, 2023

Anticipated

Primary completion date

Sep, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

Are pregnant female volunteers aged 18 years or older;

Gestation beyond the first trimester as evidenced by gestational age of greater than or equal to 14 weeks and 0 days;

Have compatible anatomy to fit a standard air-filled occlusive cuff size (an upper limb circumference ranging 17 cm to 40 cm);

Are willing and able to volunteer to provide multiple blood pressure measurements as required for study procedures;

Are able and willing to provide written informed consent.

Exclusion Criteria:

Exhibit signs or symptoms or have a current diagnosis of peripheral vascular disease;

Have current, uncontrolled circulatory shock or cardiac arrhythmias that pose risk to the patient or could interfere with completion of study blood pressure determinations;

Exhibit injuries, deformities, intravenous lines, or other abnormalities that, in the opinion of the investigator, may prevent proper occlusive cuff application or functioning; the investigator, may prevent proper occlusive cuff application or functioning;

Have contraindications to blood pressure measurement methods used in the study or any medical condition where study procedures could pose a risk to the subject/patient's physiological stability, in the opinion of a medically qualified investigator.

Study Design

Enrollment

170 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Blood Pressure Collection

This study has only 1 arm; investigational NIBP measurements will be collected using a NIBP Auscultatory Algorithm with alternating NIBP measurements collected using a reference sphygmomanometer.

Interventions

Collecting blood pressure measurements with noninvasive blood pressure device

Noninvasive blood pressure measurements will collected based on the recommendations of the International Organization for Standardization (ISO) 81060-2:2018+A1:2020 Non-invasive sphygmomanometers -Clinical investigation of intermittent automated measurement type. This study has only 1 arm; investigational NIBP measurements will be collected using a NIBP Auscultatory Algorithm with alternating NIBP measurements collected using a reference sphygmomanometer.

Primary outcome measure

  • Collection of per subject NIBP measurements [ Time Frame: Start of blood pressure acquisition until three valid pairs obtained, approximately one hour ]

Central Contacts and Locations

Central contacts

GEHC Patient Care Solutions Research Program Integrator

+1-262-290-6037meghan.terry@ge.com

Locations

Washington University in St. Louis

Recruiting

Saint Louis, Missouri, United States, 63110

Contacts

More Information

Sponsor

GE Healthcare

Last update posted

Mar 29, 2023

Last verified

Mar, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by GE Healthcare on 2023-03-29.