Clinical trials: SpO2
Healthy, Hypoxia
Prospective Study to Validate the Clinical Accuracy of the Norbert Device to Measure Oxygen Saturation
The purpose of this study is to evaluate the SpO2 accuracy and performance of the Norbert Device during non-motion conditions over the range of 70-100% SaO2 as compared to arterial blood samples assessed by CO-oximetry for SpO2…
- Trial name
- NCT05685654
- Testing
- Norbert Device
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- Norbert Health
Healthy
Clinical Validation for SpO2 Function of Masimo INVSENSOR00069
Assess the accuracy of INVSENSOR00069's peripheral oxygen saturation (SpO2) against contemporaneous measurement from arterial blood gas (ABG) analysis.
- Trial name
- NCT06120777
- Testing
- INVSENSOR00069
- Where
- United States
- Volunteers
- 89 people, healthy volunteers welcome
- Sponsor
- Masimo Corporation
Hypoxia
Polso SpO2 Accuracy Validation Study
The purpose of this study is to validate the oxygen saturation (SpO2) accuracy of the Polso Monitoring System during non-motion conditions over the range of 70-100% SaO2 as compared to arterial blood samples assessed by…
- Trial name
- NCT03735329
- Testing
- Diagnostic test of SPO2
- Where
- United States
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- ChroniSense Medical Ltd.
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
SpO2
Accuracy of Pulse Oximeters With Profound Hypoxia
This project aims to test the accuracy of pulse oximeters during mild, moderate, and severe hypoxia, i.e., a range of arterial HbO2 saturation from 100 down to 70%.
- Trial name
- NCT05322382
- Testing
- A-line
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- CardiacSense Ltd.
Hypoxia
Accuracy of Pulse Oximeters With Profound Hypoxia At Rest (NIHO18)
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
- NCT05807464
- Testing
- Pulse Oximeter
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Nihon Kohden
Hypotension
Clinical Validation of Vital-PICASO for Predicting Hypotension Within 24 Hours in General Ward Inpatients
This retrospective study evaluated the clinical performance of Vital-PICASO, an artificial intelligence-based biological signal analysis software designed to predict the risk of hypotension within 24 hours using vital-sign data…
- Trial name
- NCT07742930
- Where
- South Korea
- Volunteers
- 648 people
- Sponsor
- Huinno AIM
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
Laboratory Testing on Healthy Volunteers to Verify SpO2 and Heart Rate (HR) Accuracy of BrOxy M
Postmarket Clinical Follow-up Study to Confirm the Performance of the Wearable Pulse-Oximeter BrOxy M (SOMBRERO)
This study is a post market clinical follow up study performed to confirm the performance of BrOxy M pulse oximeter in comparison with a reference, CE marked, pulse oximeter equipment in a controlled desaturation study over a…
- Trial name
- SOMBRERO (NCT04810221)
- Testing
- Controlled desaturation study
- Where
- Italy
- Volunteers
- 19 people, healthy volunteers welcome
- Sponsor
- Life Meter srl
Healthy
Accuracy of SpO2 for Noninvasive Pulse Oximeter Sensor (RD DCI)
In this study, the level of oxygen within the blood will be reduced in a controlled manner by reducing the concentration of oxygen the study volunteer breathes.
- Trial name
- NCT03124797
- Testing
- RD DCI Sensor
- Where
- United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Masimo Corporation
Evaluation of SpO2 Performance
Feasibility and Performance Evaluation of INVSENSOR00024
This is a prospective, non-randomized, single arm study design to evaluate SpO2 performance of the INVSENSOR00024 sensors in the neonatal population in a clinical environment using convenience sampling.
- Trial name
- NCT03831282
- Testing
- RD SET Neo SpO2
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Masimo Corporation
Cardiac Disease, Respiratory Disease
Clinical Use Cases Assessment of the Gabi System in Young Children With Underlying Medical Conditions (BRIDGE Study)
Subjects will use the Gabi system on a daily basis for 3 months, each time the subject is resting or asleep. The Gabi system will recording the SpO2, pulse rate, respiratory rate and movements of the subject.
- Conditions
- Cardiac Disease, Respiratory Disease, Congenital Cardiac Defect, Cardiovascular Diseases
- Trial name
- BRIDGE (NCT05319236)
- Testing
- Gabi System
- Where
- 4 sites in United States, Belgium
- Volunteers
- 101 people
- Sponsor
- Gabi SmartCare
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
Healthy
Accuracy of Continuous SpO2 Measurement in Adults
The purpose of this study is to compare the accuracy of the Sotera ViSi, an investigational device, to standard devices in estimating the level of blood oxygen (SpO2) in adult human subjects.
- Trial name
- SPO2 (NCT01183338)
- Where
- United States
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- Sotera Wireless, Inc.
Healthy
Accuracy Validation of a Pulse Oximetry Monitor
The purpose of this study is to conduct an oxygen saturation (SpO2) accuracy validation comparing prototype pulse oximeter oxygen saturation measurements directly to arterial blood saturation during non-motion conditions over the…
- Trial name
- NCT02506010
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- Medtronic - MITG
Hypoxia
Induced Hypoxia Study for Validation of SpO2 Accuracy
Validate Non-Motion SpO2 Accuracy from 70%-100% of various pulse oximeter/ sensor combinations and various OEM pulse oximeter modules and sensor combinations during induced hypoxia (desaturation).
- Trial name
- NCT00788983
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Nonin Medical, Inc
Oxygen Deficiency, Oxygen Therapy
Sustainable Preservation of Essential Oxygen Resources: A Phase 4 Crossover Study of the BUFEO System: SAVE O2
The current methods of oxygen supply administer medicinal oxygen to the patient at a constant flow. Oxygen is being delivered when the patient needs it (at inhalation) and when the patient does not need it (at exhalation and at…
- Trial name
- SAVEO2 (NCT05677009)
- Testing
- BUFEO system, Standard of Care
- Where
- Colombia
- Volunteers
- 20 people
- Sponsor
- Oxfo Corporation
PULSE OXIMETRY
SPO2 VALIDATION STUDY - PHILIPS FAST 2025
Clinical investigation is to validate the SpO2 accuracy of the M1133AX5, M1133AX6, and AlarX4 (nasal ala application) SpO2 sensors under test with the Philips FAST Pulse Oximetry technology.
- Trial name
- NCT07221526
- Testing
- NO INTERVENTION
- Where
- United States
- Volunteers
- 86 people, healthy volunteers welcome
- Sponsor
- Philips Clinical & Medical Affairs Global
Oxygen Saturation
Convenience Sample Data Collection for INVSENSOR00045
This clinical investigation is to collect data to provide additional support for form, fit, and function of INVSENSOR00045 in the neonatal clinical environment when used by hospital's personnel and reference co-oximeter.
- Trial name
- NCT04894669
- Testing
- INVSENSOR00045
- Where
- United States
- Volunteers
- 7 people, healthy volunteers welcome
- Sponsor
- Masimo Corporation
Oximetry
Accuracy Assessment of Beddr Oximeter
Accuracy performance of Beddr oximeter
- Trial name
- NCT03710993
- Testing
- oximeter
- Where
- United States
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- Hancock Medical, Inc.