Clinical trials: Oximetry
Pulse Oximeter Validation
Evaluation of Accuracy of the Owlet OSS 3.0 Sensor in the Neonatal Population
The sponsor of this study, Owlet Baby Care, Inc., is comparing the accuracy of their pulse oximeter Sensor with the measurements of oxygen levels in newborns who are already being monitored with arterial blood samples.
- Trial name
- NCT06771206
- Testing
- Owlet pulse oximeter neonatal accuracy validation
- Where
- 2 sites in United States
- Volunteers
- 20 people
- Sponsor
- Owlet Baby Care, Inc.
Hypoxia
RDS MultiSense® SpO2 Validation Study
The purpose of this clinical study is to validate the oxygen saturation (SpO2) accuracy of the RDS MultiSense® Pulse Oximetry during non-motion conditions over the range of 70-100% arterial oxygen saturation (SaO2) as compared to…
- Trial name
- NCT05359328
- Testing
- Pulse Oximeter, Respiratory Rate, Heart Rate and Arterial line
- Where
- United States
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Rhythm Diagnostic Systems
Oximetry
Accuracy of Pulse Oximeters With Profound Hypoxia
To test the accuracy of a non-invasive blood oxygen saturation monitor which is placed on a subject with profound hypoxia.
- Trial name
- NCT04324385
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Compumedics Limited
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
Sleep Disordered Breathing
Oxygen Monitoring of Patients After Surgery on the Hospital General Care Floor
The pain medication given after major surgery may cause some patients to stop breathing for periods of time especially at night time. An oxygen monitor may reflect this abnormal breathing pattern.
- Trial name
- NCT01082575
- Testing
- Oxygen Monitoring
- Where
- 3 sites in United States
- Volunteers
- 100 people
- Sponsor
- Medtronic - MITG
Oximetry, Pulse
Accuracy of Pulse Oximeters With Profound Hypoxia
The aim of this project is to test the accuracy of pulse oximeters during mild, moderate and severe hypoxia. This is done by comparing the reading of the pulse oximeter during brief, steady state hypoxia with a gold-standard…
- Trial name
- NCT02571686
- Testing
- Surveyor S4
- Where
- United States
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Mortara Instrument
Surgery
Validation of Noninvasive Hemoglobin, Comparison of PVI to Standard Methods, and Validation of Clinical Efficacy of ORI
The study goal is to establish the correlation of hemoglobin values determined by the noninvasive pulse oximetry-determined hemoglobin (SpHb) system with hemoglobin as measured by other validated devices.
- Trial name
- NCT02841397
- Testing
- Masimo Pulse CO-Oximeter
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Masimo Corporation
Hypoxia
SpO2 Accuracy Comparison of Smart Sock V. 2 SpO2 to Arterial Blood CO-Oximetry
Pulse oximetry monitoring is considered a standard physiological measurement and is used by clinicians in everyday situations to estimate arterial oxygen saturation.
- Trial name
- NCT03630016
- Testing
- Pulse oximetry with Owlet BabySat v1.0 sensor
- Where
- United States
- Volunteers
- 11 people, healthy volunteers welcome
- Sponsor
- Owlet Baby Care, Inc.
Total Aortic Arch Replacement
Near-Infrared Spectroscopy Comparison Study
The objective of this study is to validate Near-Infrared (NIRS) monitoring in patients undergoing circulatory arrest. This study will compare two-wavelength NIRS INVOS System, Somanetics; Troy, MI) with four-wavelength NIRS…
- Trial name
- NCT01352260
- Where
- United States
- Volunteers
- 17 people
- Sponsor
- Nonin Medical, Inc
Oximetry
Accuracy of ScanWatch Pulse Oximeter With Profound Hypoxia
Performance testing of pulse oximeters. The protocol involves brief stable arterial oxygen desaturation in healthy volunteers and sampling arterial blood when a stable level of hypoxia has been attained.
- Trial name
- NCT04380389
- Testing
- hypoxia
- Where
- United States
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- Withings
Healthy
Pulse Oximetry_Performance During Severe Signal Interference - PCBA-1 (Printed Circuit Board Assembly)
Determine accuracy specifications and labeling claims of a pulse oximeter in a diverse subject population during severe signal interference over a specified saturation range.
- Trial name
- NCT01747473
- Where
- United States
- Volunteers
- 17 people, healthy volunteers welcome
- Sponsor
- Medtronic - MITG
Pulse Oximetry
U-TruSignal SpO2 Testing in Neonates
The purpose of the study is to demonstrate proper function of the U-TruSignal device via clinical performance testing in a neonatal human subject population under standard clinical conditions.
- Trial name
- NCT03383757
- Testing
- SpO2 Sensor application & blood draw
- Where
- 2 sites in Finland, India
- Volunteers
- 117 people
- Sponsor
- GE Healthcare
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.
Hypoxia
Pulse Oximeter Accuracy During Stable Hypoxia Plateaus
The aim of this study is to determine the accuracy of devices called pulse oximeters, which measure blood oxygen by shining light through fingers, ears or other skin, without requiring blood sampling.
- Trial name
- NCT07408388
- Testing
- Pulse Oximeter, Induced hypoxia through breathing nitrogen-air-carbon dioxide mixture
- Where
- United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Nihon Kohden
Hypoxia
RDS MultiSense® SpO2 Calibration
Data will be collected with the MultiSense® pulse oximetry system during non-motion conditions over the range of 70-100%. A Clinimark reference system, previously correlated to arterial blood CO-Oximetry will be the basis for…
- Trial name
- NCT05466942
- Testing
- Pulse Oximeter, Respiratory Rate, Heart Rate
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Rhythm Diagnostic Systems
Oxygen Saturation Measurement
Controlled Desaturation Study for Perin Health Patch Validation
This study aims to test the accuracy of the Perin Health Patch (PHP), a non-invasive, chest-worn device that measures blood oxygen levels, by comparing its readings to a standard pulse oximeter device.
- Trial name
- NCT06680700
- Testing
- Perin Health Patch
- Where
- United States
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Perin Health Devices
Sleep Disorders
Evaluation of WP200 With the Unified Probe (WP200U)
The prevalence of OSAS is estimated at 2% and 4% for adult women and men respectively, most of whom are undiagnosed and untreated.
- Trial name
- NCT01929447
- Where
- Israel
- Volunteers
- 75 people, healthy volunteers welcome
- Sponsor
- Itamar-Medical, Israel
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
Hypoxia
N600X Low Saturation Accuracy Validation
To compare pulse oximetry saturation measurements, during normal to low saturation, to saturation measurements made by a multi-wavelength CO-oximeter, taken from arterial blood samples from healthy human subjects.
- Trial name
- NCT05532670
- Testing
- Non-Invasive Controlled Hypoxia
- Where
- United States
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- Medtronic - MITG
Sleep Apnea, Obstructive
Oxygen Saturation Monitoring During Surgery
Patients with Obstructive Sleep Apnea (OSA) have cyclical patterns of lower blood oxygen during sleep because of repeated episodes of upper airway obstruction that cause their breathing to stop.
- Trial name
- NCT01098851
- Where
- United States
- Volunteers
- 21 people
- Sponsor
- Medtronic - MITG