Trans-abdominal Fetal Pulse Oximetry; Tissue Light Scattering and Signal Integrity

Raydiant Oximetry

Status: Completed

Conditions: Fetal Hypoxia

Treatments: Device: GEN 3 Monitoring of Fetus

Study type: Interventional

Funder types: Industry

Identifiers

NCT04876846

GEN 3

Details and patient eligibility

About

The overall purpose of this study is to evaluate maternal-fetal tissue light scattering properties. The objectives of the study are: (i) integrate established mathematical principles of oxygen saturation to model with increasing accuracy the "body in a body" problem of fetus in mother; similar to existing pulse oximeters, the calculations will be integrated into software in the final commercial product; (ii) obtain human measurements against which both computational models and animal data can be compared.

Full description

This is a prospective, observational, non-significant risk study. The study involves using non-invasive devices that measure fetal depth and tissue light scattering on the maternal abdomen. Ultrasound assessment will be performed, and multiple images taken at various locations on the abdomen. All images will be captured with minimal probe pressure applied to allow accurate ascertainment of depth. Images will be anonymized, and all study data will be coded with a unique identifier. Key maternal descriptive statistics will be recorded from the medical record including BMI, height, weight (kg), parity, age and gestational age.

The ISS device is a customized commercial frequency domain oximeter (Imagent, ISS Inc.; http://www.iss.com/biomedical/instruments/imagent.html) with multiple laser sources and multiple detectors. This instrument is safe, uses non-ionizing radiation.

The Raydiant Lumerah device is a non-invasive fetal pulse oximeter that measures fetal arterial oxygen saturation using safe, non-invasive, transabdominal near-infrared spectroscopy. The Lumerah device will be positioned on the maternal abdomen of women volunteers in the late 3rd trimester.

Enrollment: 9 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Women with singleton, healthy pregnancy at gestational age ≥ 36 weeks
2. Age > 18 years
3. Willing to come in for testing outside of routine business hours (including Saturdays)

Exclusion criteria

1. Age <18
2. Multiple gestation (twins, triplets)
3. Presentation other than vertex or breech
4. < 36 weeks of gestation

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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9 participants in 1 patient group

Interventional/Observational

Experimental group

Description:

The Gen 3 device will be positioned on the maternal abdomen to measure light scattering and absorption for a period of about 10-20 minutes. A second measurement may be obtained for a total of up to 40 minutes. Subject's end their participation in the study after that time period.

Treatment:

Device: GEN 3 Monitoring of Fetus