Clinical trials: SPO2
Neonatal Respiratory Distress, Oxygenation
Neonatal Oximeter Bias Study
The study aims to determine if there is a systematic difference (bias) between pulse oximeters used in control systems for automated oxygen delivery (A-FiO2) and those used in monitoring systems.
- Trial name
- NOB (NCT06817850)
- Where
- Czechia
- Volunteers
- 40 people
- Sponsor
- Czech Technical University in Prague
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
Therapy, Oxygen Inhalation
Effect of Halotherapy in Children With Asthma
Introduction: Asthma is a chronic respiratory disease that can affect all age groups and is characterized by episodic and reversible wheezing, shortness of breath, chest tightness and cough attacks.
- Trial name
- NCT06250452
- Testing
- Halotherapy (Salt Therapy)
- Where
- 2 sites in Turkey (Türkiye)
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- Igdir University
Neonatal Disease, Altitude Hypoxia
Reference Interval for SPO2 in Neonates at High Altitudes During First 2 Hours and Umbilical Artery Blood Gas
Pulse oximetry offers real time and non-invasive estimation of arterial oxygen saturation in a cost-effective way, and has become a critical tool in guiding the usage of supplemental oxygen in sick newborns.
- Trial name
- NCT05468515
- Testing
- pulse oxygen saturation
- Where
- China
- Volunteers
- 956 people, healthy volunteers welcome
- Sponsor
- Children's Hospital of Fudan University
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
Paediatric Asthma
Design, Development and Evaluation of a Digital Health Assistant for Paediatric Asthma
This study is to evaluate the efficacy of the digital health assistant (DHA) "Alex" in improving asthma control in asthmatic children and adolescents aged 10 to 19 compared to their baseline values.
- Trial name
- ALEX (NCT07472283)
- Testing
- Phase I (months 1-3): DHA core functionality, Phase II (months 3-6): platform augmentation, Embedded qualitative study
- Where
- 5 sites in Romania
- Volunteers
- 42 people
- Sponsor
- University Children's Hospital Basel
Spo2
SpO2 Data Collection in Pediatric Patients Using INVSENSOR00061
This is a prospective, non-randomized data collection study to evaluate the form, fit, and function of INVSENSOR00061.
- Trial name
- NCT05896267
- Testing
- Masimo INVSENSOR00061
- Where
- United States
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Masimo Corporation
Apnea+Hypopnea, Tracheal Dilatation
Tracheal Dilatation in Pediatric Patients With Acquired Tracheal Stenosis, and the Effects of Apneic Oxygenation
The study presents an alternative method of tracheal dilatation in pediatric patients with acquired tracheal stenosis. Dilatation is performed by the use of balloon catheter connected with manometer, that is bronchoscopic guided…
- Conditions
- Apnea+Hypopnea, Tracheal Dilatation, Igel, Tracheal Stenosis
- Trial name
- NCT05028023
- Testing
- Apneic oxygenation - supplemental high flow oxygen administration by an apneic way
- Where
- Greece
- Volunteers
- 5 people
- Sponsor
- Aristotle University Of Thessaloniki
Cystic Fibrosis, Healthy
Utilizing Exhaled Breathe Condensate Collection to Study Ion Regulation in Cystic Fibrosis
Our aims were to determine if exhaled breath condensate (EBC) could detect differences in ion regulation between cystic fibrosis (CF) and healthy and measure the effect of the albuterol on EBC ions in these populations.
- Trial name
- NCT01880723
- Testing
- Albuterol
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- University of Arizona
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
Drug-resistant Partial Epilepsy
National Network for the Study of Predictors and Prevention of Sudden Unexpected Death in Drug-resistant Partial Epilepsies
Sudden unexpected death in epilepsy (SUDEP) is the main concern of professionals and patient associations involved in epilepsy. These represent a priority for the Ligue Française Contre l'Epilepsie (LFCE).
- Trial name
- REPOMSE (NCT02572297)
- Testing
- video-EEG
- Where
- France
- Volunteers
- 1,072 people
- Sponsor
- Hospices Civils de Lyon
Neonatal Respiratory Distress, Very Low Birth Weight Infant
Evaluation of the Impact of SpO2 Averaging Time on Performance of an Automatic FiO2 Control System: a Randomized Study
The aim of the study is to determine the preferred oximeter averaging setting during automated control of FiO2 (A-FiO2) in infants receiving respiratory support and supplemental oxygen.
- Trial name
- NCT05274386
- Testing
- Fabian ventilator with PRICO system (Acutronic Medical Systems AG, Hirzel, Switzerland); SpO2 averaging time set to 4to6 s, Fabian ventilator with PRICO system (Acutronic Medical Systems AG, Hirzel, Switzerland); SpO2 averaging time set to 10 s, Fabian ventilator with PRICO system (Acutronic Medical Systems AG, Hirzel, Switzerland); SpO2 averaging time set to 16 s
- Where
- Czechia
- Volunteers
- 10 people
- Sponsor
- Czech Technical University in Prague
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
RDS - Infants, TTN
Effect of Cannula Size on Oxygen Saturation During Nasal High Flow Therapy in Newborns
Treatment with nasal high flow therapy (NHF) is an increasingly popular method of respiratory support in newborns. Safe and effective use of NHF requires selection of an appropriate nasal prong-to-nares ratio because leak can…
- Trial name
- NCT04459429
- Testing
- Change of cannula size
- Where
- Armenia
- Volunteers
- 25 people
- Sponsor
- Erebouni Medical Center
Neonates, White Noise
Effects of White Noise and Lullaby on Vital Signs of Term Newborns in Neonatal Intensive Care
This clinical study aims to evaluate how two types of gentle sounds - white noise and a traditional Turkish lullaby ("Dandini Dandini Dastana") - affect the vital signs of term newborns cared for in the Neonatal Intensive Care…
- Conditions
- Neonates, White Noise, Non-Pharmacological Interventions, Auditory
- Trial name
- NCT07590479
- Testing
- White Noise Exposure, Lullaby Listening
- Where
- Turkey (Türkiye)
- Volunteers
- 70 people
- Sponsor
- Başakşehir Çam & Sakura City Hospital
Respiratory Disease, Respiratory Distress Syndrome
Oxygenation Efficacy of "Intrinseque Health" Non-Rebreathing Mask ("IHNRM")
Based on early bench-testing data and subsequent clinical case studies in the U.S., "Intrinseque Health" non-rebreathing mask (IHNRM) has delivered virtual elimination of air entrainment and preferential delivery of all available…
- Conditions
- Respiratory Disease, Respiratory Distress Syndrome, Respiratory Failure
- Trial name
- NCT06310629
- Testing
- High Flow Nasal Cannula, "Intrinseque Health" Non-Rebreathing Mask ("IHNRM")
- Where
- Taiwan
- Volunteers
- 90 people
- Sponsor
- China Medical University Hospital
Orthodontic
The Influence of Anatomical Characteristics and Orthodontic Force on Pulpal Oxygen Saturation: A Clinical Study Using Cone-Beam Computed Tomography (CBCT)
The primary objective of this clinical protocol is to evaluate and compare the physiological responses of dental pulp to two different magnitudes of orthodontic force during active orthodontic treatment.
- Trial name
- NCT07630818
- Testing
- 150g Orthodontic Force Application, 50g Orthodontic Force Application
- Where
- Vietnam
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- Can Tho University of Medicine and Pharmacy
Evaluation of SpO2 Performance
Feasibility and Performance Evaluation for INVSENSOR00024
This is a prospective, non-randomized, single arm study design to evaluate SpO2 performance of the RD SET Neo investigational pulse oximeter sensors in the neonatal population using convenience sampling in a clinical environment.
- Trial name
- NCT03570255
- Testing
- RD SET Neo SpO2
- Where
- United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Masimo Corporation
SpO2, Nasal Alar Collapse, Bilateral
Project Mountain - Comparing SpO2 and SaO2 for Accuracy
The main goal of this study is to look at the performance of the neonatal, infant, and pediatric Philips SpO2 sensors with the Philips FAST Pulse Oximetry technology.
- Conditions
- SpO2, Nasal Alar Collapse, Bilateral, Oxygen, Measurement
- Trial name
- NCT06372106
- Testing
- SaO2 Sampling
- Where
- 5 sites in United States
- Volunteers
- 560 people, healthy volunteers welcome
- Sponsor
- Philips Clinical & Medical Affairs Global
Respiratory Failure, Hypoxemia
Comparison of Pulse Oximetry (SpO2) With Different Oximeters and Arterial Saturation (SaO2): Oxygap2 Study
The oximeter is used to monitor intensive care patients undergoing oxygen therapy. It indicates pulsed oxygen saturation (SpO2), a reflection of arterial oxygen saturation (SaO2) which enables detection of hypoxemia and…
- Conditions
- Respiratory Failure, Hypoxemia, Hyperoxemia
- Trial name
- Oxygap 2 (NCT06102499)
- Testing
- SpO2 and SaO2 comparison
- Where
- 3 sites in Canada
- Volunteers
- 200 people
- Sponsor
- Laval University