[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100627521":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":10,"centralContacts":24,"locations":30,"responsibleParty":73,"collaborators":10,"id":75,"slug":76,"hasResults":77,"nctId":78,"briefTitle":79,"officialTitle":79,"acronym":80,"eligibilityCriteria":81,"healthyVolunteers":77,"sex":82,"minAge":83,"maxAge":10,"enrollmentInfo":84,"targetDuration":10,"studyType":87,"phases":10,"briefSummary":88,"conditions":89,"keywords":91,"overallStatus":33,"whyStopped":10,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":112},{"fullName":5,"class":6},"Philips Clinical & Medical Affairs Global","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Adult Inpatients",null,"Adult participants (aged 18 years and older) will undergo noninvasive physiological monitoring using adult-appropriate Philips SpO₂ sensors during a single study visit. Each participant completes two separate 20-minute recording cycles. The first cycle includes simultaneous monitoring with the M1191T adult finger sensor (\\>50 kg) and the nasal alar sensor (989803205391; ≥15 kg). The second cycle includes the M1191T adult finger sensor and the M1194A ear sensor (\\>40 kg). During both cycles, capnography is recorded concurrently using the LoFlo Sidestream etCO₂ sensor (M2741A) connected to an adult oral\u002Fnasal cannula (989803206671). All monitoring is observational, and device outputs are not used for clinical decision-making.",[13],"Device: Physiological Monitoring with SpO₂ Sensors and Capnography",{"label":15,"type":10,"description":16,"interventionNames":17},"Pediatric Inpatients","Pediatric participants aged 4-17 years receiving physiological monitoring with pediatric-appropriate Philips SpO₂ sensors (M1192A finger glove for 15-50 kg; nasal alar sensors for ≥15 kg; ear sensor M1194A for \\>40 kg when age ≥12 years). Participants complete one or two 20-minute recording cycles depending on age\u002Fweight per protocol. Capnography is collected using the LoFlo Sidestream etCO₂ sensor with pediatric oral\u002Fnasal cannula (989803206681).",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":10},"DEVICE","Physiological Monitoring with SpO₂ Sensors and Capnography","Participants will undergo noninvasive physiological monitoring with commercially available Philips SpO₂ sensors (adult finger sensor M1191T; pediatric finger glove M1192A; nasal alar sensors 989803205391; adult\u002Fpediatric ear sensor M1194A) connected to Philips MP5 or PM6300 patient monitors configured with standard FAST Pulse Oximetry technology. A LoFlo Sidestream etCO₂ sensor (M2741A) with an adult or pediatric oral\u002Fnasal cannula (989803206671 or 989803206681) will be used to collect reference capnography waveforms. All monitoring is observational, and no device output is used for clinical decision-making.",[9,15],[25],{"name":26,"role":27,"phone":28,"phoneExt":10,"email":29},"Nero Evero, Clinical Study Manager, MS","CONTACT","+1 720-201-7689","nero.evero@philips.com",[31,53],{"facility":32,"status":33,"city":34,"state":35,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"Duke University Hospital","RECRUITING","Durham","North Carolina","27710","United States","US",{"type":40,"coordinates":41},"Point",[42,43],-78.89862,35.99403,{"lat":43,"lon":42},[46,50],{"name":47,"role":27,"phone":48,"phoneExt":10,"email":49},"David MacLeod, Associate Professor of Anesthesiology, MBBS","919-681-6437","david.macleod@duke.edu",{"name":51,"role":52,"phone":10,"phoneExt":10,"email":10},"David MacLeod, MBBS","PRINCIPAL_INVESTIGATOR",{"facility":54,"status":55,"city":56,"state":57,"zip":58,"country":59,"countryCode":60,"cosmosGeoPoint":61,"geoPoint":65,"contacts":66},"Ysbyty Gwynedd","NOT_YET_RECRUITING","Bangor","Gwynedd","LL57 2PW","United Kingdom","UK",{"type":40,"coordinates":62},[63,64],-5.66802,54.66079,{"lat":64,"lon":63},[67,71],{"name":68,"role":27,"phone":69,"phoneExt":10,"email":70},"Manohar Joishy, Clinical Director, Paediatrics, MD","+44 03000 841 295","manohar.joishy@wales.nhs.uk",{"name":72,"role":52,"phone":10,"phoneExt":10,"email":10},"Manohar Joishy, MD",{"type":74,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100627521","respiration-from-pleth-validation-100627521",false,"NCT07449715","Respiration From Pleth Validation","RfP Validation","Inclusion Criteria:\n\n1. Adult Participants (defined as aged 18 years or older): Willing and able to understand and provide written informed consent\n2. UK Pediatric subjects:\n\n   * Aged 16 years and older willing and able to understand and provide written informed consent\n   * Aged 4-15 years and their legal guardians willing and able to understand and provide written informed consent\u002Fassent\n3. US Pediatric Participants: aged 4 to 17 years and their parent\u002Flegal guardian are willing and able to understand and provide written informed assent\u002Fconsent\n4. Participant weight is within intended use of at least one SpO2 sensor under test as time of enrollment.\n\n   * M1191T, adult participants \\> 50 kg\n   * M1192A, pediatric participants 15-50 kg\n   * Nasal Alar Sensor, adult and pediatric participants ≥ 15 kg\n   * M1194A, adult and pediatric participants \\> 40 kg\n5. Willing and able to wear study devices for the entirety of study procedures\n6. Undergoing regular spot-check measurements as per the site's standard of care\n\nExclusion Criteria:\n\n1. Palliative patients\n2. Patients with tremors, cardiac pacemakers, or known atrial fibrillation\n3. Patients receiving oxygen supplementation at the time of study participation\n4. Critically ill patients with severe physiological instability\n5. Pregnant and\u002For lactating patients (self-reported)\n6. Injury, wounds, and\u002For physical malformation of any sensor application site (e.g., fingers, nose, ear)\n7. Self-reported severe contact allergies to standard adhesives, latex, and\u002For other materials found in pulse oximetry sensors\n8. Unwillingness or inability to remove colored nail polish or artificial nails from the application site\n9. Unwillingness or inability to remove foreign objects, such as nose and\u002For ear jewelry from sensor application sites\n10. Nail fungus on application site\n11. Severe dermatitis or hyperkeratosis (e.g. ichthyosis) at sensor application site","ALL","4 Years",{"count":85,"type":86},113,"ESTIMATED","OBSERVATIONAL","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. Adult and pediatric inpatients will undergo noninvasive monitoring using age- and weight-appropriate SpO₂ sensors and capnography, with capnography serving as the reference standard. The study assesses accuracy, mean bias, precision, and time to first valid respiratory-rate value across continuous and spot-check conditions. No device outputs are used for clinical decision-making, and all procedures occur during a single study visit.",[90],"Respiratory Rate Monitoring",[92,93,94,95,96,97,98,99,100,101,102],"Respiration rate","Capnography","Plethysmography","RfP Algorithm","Respiration from plethysmography","Device performance validation","Pulse oximetry","Vital signs monitoring","FAST Pulse Oximetry technology","SpO₂ sensors","Pleth-derived respiratory rate","2026-02-26",{"date":105,"type":106},"2026-03-04","ACTUAL",{"date":108,"type":106},"2026-02-06",{"date":110,"type":86},"2026-05-25",{"name":5,"class":6},2]