Clinical trial NCT05789849: Data Collection for Validation of an NIBP Algorithm in Pregnant Women
Official title: Data Collection for Validation of a Noninvasive Blood Pressure Auscultatory Algorithm - Pregnant Women
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Blood Pressure
Lead sponsor: GE Healthcare
Sponsor class: INDUSTRY
First posted: 2023-03-29
Enrollment: 170
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is an open label, single-site, single arm, prospective, pivotal study including a training phase and a data collection phase.
Primary purpose: OTHER

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.

Detailed description: The purpose of the study is to collect data per subject NIBP measurements by (1) oscillometric means using the GE NIBP Auscultatory Algorithm and (2) by conventional auscultatory means in a pregnant population. These measurements include Systolic BP (mmHg) and Diastolic BP (mmHg). The secondary objective of this study is to collect per procedure and log files from the device. The safety objective of this study is to collect safety information, including type and number of adverse events, serious adverse events and device issues.

This is an open label, single-site, single arm, prospective, pivotal study including a training phase and a validation phase with demographics-based stratification quota. Subjects are sequentially tested with investigational and reference blood pressure measurements.

Eligibility criteria: 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.

Primary outcomes:
measure: Collection of per subject NIBP measurements
timeFrame: Start of blood pressure acquisition until three valid pairs obtained, approximately one hour
Secondary outcomes:
measure: Collection of per procedure and device log files.
timeFrame: Start of blood pressure acquisition until three valid pairs obtained, approximately one hour
Other outcomes:
measure: Number of Safety Events and Device Issues
timeFrame: Start of blood pressure acquisition until three valid pairs obtained, approximately one hour
Locations:
city: Saint Louis
country: United States
facility: Washington University in St. Louis
state: Missouri
Study officials:
affiliation: Division of Maternal-Fetal Medicine Washington University in St Louis School of Medicine
name: Nandini Raghuraman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Washington University School of Medicine
name: Adithya Bhat, MD
role: PRINCIPAL_INVESTIGATOR
References: