Clinical trials: Oximetry
Hypoxemia
Oxygen Saturation Alarms in the Neonatal Intensive Care Unit
Infants will be observed in the neonatal intensive care unit for 4 hours. The observer will note the timing of oxygen saturation alarms, staff response, and interrupted staff activities.
- Trial name
- NCT01085539
- Where
- 3 sites in United States
- Volunteers
- 50 people
- Sponsor
- Medtronic - MITG
Regional Saturation of Oxygen (rSO2)
Performance Comparison of Masimo O3 Regional Oximetry Sensors in Neonates
The aim of the study is to compare the performance of the O3 cerebral oximeter and sensor to a 510(k) cleared NIRS (Near-Infrared Spectroscopy) device on neonatal subjects based on data collected from the cutaneously placed…
- Trial name
- NCT03828487
- Testing
- Masimo O3 Neonatal Sensors, 510(k) cleared sensor
- Where
- United States
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Masimo Corporation
Fetal Distress
Trans-abdominal Fetal Pulse Oximetry: Signal Integrity
This project is set up to advance and integrate the 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,
- Trial name
- NCT04081623
- Testing
- Raydiant Oximetry Sensing System
- Where
- United States
- Volunteers
- 9 people, healthy volunteers welcome
- Sponsor
- Raydiant Oximetry, Inc.
Oxygen Titration in Preterm Infants to Manage Lung Disease
IntellO2 vs Manual Control for Optimizing Oxygenation in Infants
The overall objective of this study is to demonstrate that the IntellO2 device providing automated control of fraction of inspired oxygen (FiO2) adjustments in spontaneously breathing infants with fluctuating arterial blood…
- Trial name
- NCT02074774
- Testing
- IntellO2, Manual control
- Where
- 2 sites in United Kingdom
- Volunteers
- 36 people
- Sponsor
- Vapotherm, Inc.
Adult Subject
Effect of Super-Oxygenated Water on Blood Oxygen Saturation
Therapeutic delivery of additional Oxygen to blood stream via hyperbaric and extracorporeal oxygenation that raises blood Oxygen saturation level, apart from oxygenation in the lungs, is known to induce tissue repair, restore…
- Trial name
- NCT07016191
- Testing
- Ingestion of Water
- Where
- United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Inhale, Inc
Respiratory Rate Monitoring
Respiration From Pleth Validation
This observational clinical investigation evaluates the performance of respiratory rate derived from the plethysmography waveform (Respiration from Pleth, RfP) using Philips FAST Pulse Oximetry technology.
- Trial name
- RfP Validation (NCT07449715)
- Testing
- Physiological Monitoring with SpO₂ Sensors and Capnography
- Where
- 2 sites in United States, United Kingdom
- Volunteers
- 113 people
- Sponsor
- Philips Clinical & Medical Affairs Global
Oxygen Saturation
Accuracy Performance Verification of the INVOS™ PM7100 System in Adults
Prospective, observational, post-market, verification study to ensure compliance to the ISO 80601-2-85:2021 standard
- Trial name
- NCT06581835
- Testing
- Observational
- Where
- United States
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- Medtronic - MITG
Hypertension
Recording of Physiological Data Via an Optical Sensor At the Fingertip Alongside with Double Auscultatory and Pulse Oximetry to Evaluate the Effectiveness of an Optical Blood Pressure Monitoring (OBPM)
The present study, OBPM_Calfree2024, with N = 85 participants minimum over 1 visit (lasting around 1h), has been designed to collect raw optical data with Aktiia.product-G2C Clinical investigational system together with several…
- Trial name
- NCT06368206
- Testing
- Investigational device Aktiia G2C, Marketed device used as reference for blood pressure monitoring: double auscultation cuff, Marketed device used as comparative device for blood pressure and pulse rate monitoring: Aktiia Bracelet G2
- Where
- Switzerland
- Volunteers
- 85 people, healthy volunteers welcome
- Sponsor
- Aktiia SA
Cardiogenic Shock, Acute Myocardial Infarction
Clinical Evaluation of NIRSense Tissue Oximetry Sensor Monitoring to Early Detect Cardiogenic Shock
This is a prospective, single-center, observational pilot study of the investigational NIRSense Tissue Oximetry Sensor System (Envello Core), a noninvasive wearable sensor patch that uses near-infrared spectroscopy (NIRS) and…
- Conditions
- Cardiogenic Shock, Acute Myocardial Infarction, Acute Decompensated Heart Failure
- Trial name
- NCT07825363
- Testing
- NIRSense Tissue Oximetry Sensor System
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- NIRSense Inc.
Healthy, Hypoxia
Controlled Acute Hypoxia Study - Abbreviated Sensor Line
The primary objective of the study is to validate the proposed claims for the OxiCable device, for pulse rate and saturation accuracy in a diverse subject population over a specified saturation range.
- Trial name
- NCT02216344
- Where
- United States
- Volunteers
- 13 people, healthy volunteers welcome
- Sponsor
- Medtronic - MITG
Fetal Hypoxia, Fetal Acidemia
Dual System Study: Transvaginal Fetal Pulse Oximetry Measurement Systems
The objective of this study is to collect and compare fetal SpO2 waveforms and reference values to inform algorithm development for signal qualification and FSpO2 calculations. Subjects are women in labor.
- Trial name
- NCT07296419
- Testing
- Fetal Pulse Oximetery
- Where
- United States
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- Raydiant Oximetry, Inc.
Hypoxemia
SpO2 Accuracy in Children
Evaluation of SpO2 Accuracy in Children with Various Skin Color
- Trial name
- NCT07168798
- Testing
- Pulse oximeter
- Where
- United States
- Volunteers
- 180 people, healthy volunteers welcome
- Sponsor
- Nihon Kohden
Pulse Oximetry
SpO2 System Accuracy Testing With Different Sensors
A study to test the accuracy of SpO2 sensors with various patient monitors, co-oximeters, and modules.
- Trial name
- NCT01613222
- Testing
- Pulse oximetry
- Where
- United States
- Volunteers
- 63 people, healthy volunteers welcome
- Sponsor
- GE Healthcare
Hypoxia
Oxitone Sp02 Hypoxia Test Versus Reference Pulse Oximetry
The purpose of this study is to conduct a SpO2 hypoxia evaluation of the Oxitone Medical Oxitone 1000 pulse oximeter. The Oxitone 1000 pulse oximeter will be evaluated during non-motion conditions over the range of 70-100% SpO2…
- Trial name
- NCT02870179
- Testing
- Pulse Oximeter
- Where
- United States
- Volunteers
- 11 people, healthy volunteers welcome
- Sponsor
- Oxitone Medical Ltd.
Healthy
SurePulse Oximeter - a Targeted Oxygenation Observation
This clinical investigation will investigate how accurate the SurePulse VS and SurePulse VS Patch (VSP) are for measuring blood oxygen levels (oxygen saturation).
- Trial name
- SPO-TOO (NCT05756816)
- Testing
- SurePulse VSP, SurePulse VS
- Where
- United Kingdom
- Volunteers
- 19 people, healthy volunteers welcome
- Sponsor
- Surepulse Medical Limited
Skin Types, Pulse Oximetry
Skin Tone Measurement Method Investigation for Pulse Oximetry
The primary objective is to gather missing information in order to form a well-founded recommendation on which is the preferred skin pigmentation measurement (PPM) methods in the context of pulse-oximetry.
- Trial name
- NCT05657665
- Testing
- Observational measurements of skin tone
- Where
- Netherlands
- Volunteers
- 12 people
- Sponsor
- Philips Clinical & Medical Affairs Global
Hypoxemia
Accuracy of Pulse Oximeters With Profound Hypoxia
The goal of this clinical trial is the acquisition of photoplethysmography signals during periods of profound hypoxia. The study is designed in accordance with ISO 80601- 2-61,2ed:2017-12 \& 2018-02.
- Trial name
- NCT06022523
- Testing
- Data acquisition using DT-400 pulse oximetry system
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Consolidated Research, Inc.
Pulse Oximetry
SpO2 Validation Study - Philips FAST 2024
Validation study to compare the accuracy of non-invasive Philips SpO2 sensors in detecting blood oxygen levels compared to invasive methods requiring a blood draw and lab analysis.
- Trial name
- FAST 2024 (NCT06484452)
- Testing
- No Intervention
- Where
- United States
- Volunteers
- 113 people, healthy volunteers welcome
- Sponsor
- Philips Clinical & Medical Affairs Global
Hypoxia
BiOSENCY BORA Band SpO2 Validation Study
The purpose of this clinical study is to validate the SpO2 accuracy of the BiOSENCY BORA BAND™ wristband Pulse Oximeter during non-motion conditions over the range of 70-100% SaO2 as compared to arterial blood samples assessed by…
- Trial name
- NCT03918018
- Testing
- BORA Band SpO2 Validation Study
- Where
- United States
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Biosency
Pulse Oximetry
SpO2 Accuracy In Vivo Testing for Neonates & Infants
The purpose of this clinical study is to validate the oxygen saturation (SpO2) accuracy of various pulse oximetry systems and sensors (new designs and/or reprocessed) during non-motion conditions as compared to arterial blood…
- Trial name
- NCT03843489
- Testing
- MEDLINE RENEWAL PULSE OXIMETRY SENSORS, Reference CO-oximetry sensor
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- Medline Industries