NELFSTPulse Oximetry Accuracy in Adults with Philips picoSAT X and Nellcor Sensors
Data Collection
Collected from today forward - ProspectiveHypoxia+1
+ Signs and Symptoms
+ Signs and Symptoms, Respiratory
Case-Only
Examining characteristics of individuals with a disease in order to identify genetic or environmental factors contributing to the condition.Summary
Study start date: March 11, 2025
Actual date on which the first participant was enrolled.This study focuses on evaluating the accuracy of the Philips picoSAT X SpO2 board with the FAST algorithm, when used in combination with Nellcor™ sensors. The goal is to confirm the saturation accuracy claims for these devices in a diverse group of adult volunteers, covering a specific range of saturation levels. This research is important as it aims to ensure the reliability and precision of these devices in measuring oxygen saturation levels, which is crucial for patient care and treatment decisions.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.27 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Case-only
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 50 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: 1. Subjects ≥ 18 and \< 51 years of age 2. Subject is willing and able to comply with study procedures and duration 3. Subject is willing to sign an informed consent 4. Subject weighs \>40kg 5. Subject is a non-smoker or has not smoked within 36 hours prior to the study 6. Cleared same day health assessment form and health screening Exclusion Criteria: 1. Subject is considered as being morbidly obese (defined as BMI \>39.5) 2. Compromised circulation, injury, or physical malformation of fingers, hands, ears or forehead/skull or other sensor sites which would limit the ability to test sites needed for the study (Note: Certain malformations may still allow subjects to participate if the condition is noted and would not affect the sites utilized) 3. Participants of childbearing potential who are pregnant, who are trying to get pregnant, or who have a urine test positive for pregnancy on the day of the study 4. Subjects with COHb levels \>3% as assessed by CO-Oximetry during the procedure 5. tHb \< 10 g/dl as assessed by CO-Oximetry during the procedure 6. MetHb ≥ 2% as assessed by CO-Oximetry during the procedure 7. Subjects with known respiratory conditions such as: 1. uncontrolled / severe asthma 2. flu or influenza type infection 3. pneumonia / bronchitis 4. shortness of breath / respiratory distress 5. unresolved respiratory or lung surgery 6. emphysema, COPD, lung disease 7. recent COVID (last 2 months) 8. Subjects with known heart or cardiovascular conditions such as: 1. hypertension: systolic pressure \>140mmHg, or diastolic pressure \>90mmHg on 3 consecutive readings 2. previous cardiovascular surgery 3. chest pain (angina) 4. heart rhythms other than a normal sinus rhythm or with respiratory sinus arrhythmia (reviewed during health screen) 5. previous heart attack 6. blocked artery 7. unexplained shortness of breath 8. congestive heart failure (CHF) 9. history of stroke 10. transient ischemic attack 11. carotid artery disease 12. myocardial ischemia 13. myocardial infarction 14. cardiomyopathy 15. implantable active medical device such as pacemaker or automatic defibrillator 9. Self-reported health conditions as identified in the Health Assessment Form 1. diabetes 2. uncontrolled thyroid disease 3. kidney disease / chronic renal impairment 4. history of seizures (except childhood febrile seizures) 5. epilepsy 6. history of unexplained syncope 7. recent history of frequent migraine headaches 8. recent symptomatic head injury, within the last 2 months 9. cancer requiring chemotherapy, radiation, or current treatment 10. subjects with known clotting disorders 11. history of bleeding disorders or personal history of prolonged bleeding from injury 12. history of blood clots 13. hemophilia 14. sickle cell trait or disease 15. current use of blood thinner: prescription or daily use of aspirin 16. subjects with Severe contact allergies to standard adhesives, latex or other materials found in pulse oximetry sensors, ECG electrodes, respiration monitor electrodes or other medical sensors 17. participants with severe allergy to iodine (only applicable if iodine is used) 18. subjects with prior or known severe allergies to lidocaine (or similar pharmacological agents, e.g. Novocain) or heparin 19. arterial cannulation within the last 30 days prior to study date, (this may exclude only one radial artery site, left or right) 20. history of clinically significant complications from previous arterial cannulation 21. Failure of Allen's test 22. unwillingness or inability to remove colored nail polish or colored artificial nails other than clear from test digits 23. other known health condition, upon disclosure in Health Assessment form at PI's discretion
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Medtronic Clinical Physiology Lab
Denver, United StatesOpen Medtronic Clinical Physiology Lab in Google Maps