Clinical trials: Oxymetry
Premature Birth
Neonatal Pulse Oximetry Sensor Study
To validate the SpO2 accuracy, bias, and precision of Medline's reprocessed pulse oximetry sensors as compared to SaO2 in arterial blood samples as assessed by CO-oximetry in neonates.
- Trial name
- NCT05250102
- Testing
- Pulse oximeter sensors
- Where
- 2 sites in United States
- Volunteers
- 23 people
- Sponsor
- Medline Industries
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
Colon Ischemia, Aortic Aneurysm
Prevention of Colon Ischemia During Aortic Aneurysm (AAA) Repair
Patients undergoing surgery on their Aorta can get ischemia, a lack of blood flow, to their intestines and colon. This is very serious, as 2 out of 3 patients who have this problem die before leaving the hospital.
- Trial name
- NCT00671203
- Testing
- Reestablish colon blood flow
- Where
- 2 sites in United States
- Volunteers
- 500 people, healthy volunteers welcome
- Sponsor
- Spectros Corporation
Surgery
Calibration and Validation of Masimo's O3 Regional Oximetry Device in Neonates, Infants and Children
The study will collect cerebral oximetry data from pediatric and neonatal subjects using the Masimo O3 regional oximetry device, for the purposes of device calibration and validation.
- Trial name
- NCT03123354
- Testing
- O3 regional oximeter sensor
- Where
- United States
- Volunteers
- 44 people
- Sponsor
- Masimo Corporation
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
Various Comorbidities
Pulse CO-Oximetry Noninvasive Monitoring and Laboratory Measurements of Subject Blood Samples
Characterize Masimo noninvasive technology in spot check reading on subjects and make comparison to invasive blood sampling tested on reference analyzers.
- Trial name
- NCT01638455
- Testing
- Noninvasive device
- Where
- United States
- Volunteers
- 2,776 people, healthy volunteers welcome
- Sponsor
- Masimo Corporation
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
Anemia
Measurement of Total Hemoglobin by Pulse Oximetry in Neonatal Population
Assess ability of Masimo SpHb sensor to demonstrate robust performance on various sensor application sites on neonates/infants
- Trial name
- NCT03120702
- Testing
- Investigational Rainbow SpHb sensor
- Where
- United States
- Volunteers
- 128 people, healthy volunteers welcome
- Sponsor
- Masimo Corporation
SpO2 (Peripheral Oxygen Saturation) Measurement Validation, SpO2
SpO2 Infant and Pediatric Study
This study evaluates the pulse oximetry (SpO₂) sensor for clinical performance, form, and fit in hospitalized infants and children (28 days to 12 years).
- Trial name
- SpO2 Peds (NCT07615738)
- Testing
- SpO2 Sensor
- Where
- United States
- Volunteers
- 180 people
- Sponsor
- GE Healthcare
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.
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
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
Healthy
Accuracy Evaluation of the Owlet OSS 3.0-M1 Sensor in Toddlers and Preschoolers
The purpose of the study is to collect information from the Owlet OSS 3.0-M1 Sensor in toddlers and preschoolers to evaluate accuracy.
- Trial name
- TOPS (NCT07321938)
- Testing
- Application and monitoring with an Owlet OSS 3.0-M1 Sensor, Reference Pulse Oximeter
- Where
- United States
- Volunteers
- 90 people, healthy volunteers welcome
- Sponsor
- Owlet Baby Care, 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.
Ischemia
Skin Flap Visible Light Spectroscopy (VLS) Oximetry for Monitoring Free-Flap Ischemia During Breast Reconstruction and Recovery
The purpose of the study is to understand the relevance of tissue oximetry measures of tissue flaps during surgery and during recovery, and to determine if T-Stat is a reliable and early method of detecting compromised flaps.
- Trial name
- NCT01173133
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Spectros Corporation
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
Cerebral Oxygenation, Pediatric ALL
Accuracy Performance Verification of the INVOS™ System in Pediatrics
Prospective, observational, multi-center trial designed to capture calibration and performance evaluation data with the INVOS™ system.
- Trial name
- INCATH (NCT05962905)
- Testing
- Blood sample, INVOS monitoring
- Where
- 5 sites in United States
- Volunteers
- 110 people
- Sponsor
- Medtronic - MITG
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
Newborn, Birth, Preterm
Pulse Oximetry Performance Comparison in Newborns
The overall purpose is to directly compare pulse rate (PR) acquisition and oxygen saturation performance between two pulse oximeters (PO) in newborns.
- Trial name
- NCT06637917
- Testing
- OxySoftN™ Neonatal-Adult SpO2 Sensor with N600X Nellcor™ Patient Monitoring System, LNCS® NEO SpO2 Sensor with RAD-97™ Pulse CO-Oximeter, 1041PTS (or similar) Kendall™ Neonatal Electrodes with IntelliVue MP5 Portable Patient Monitor
- Where
- 3 sites in United States
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Medtronic - MITG