Oxygen Saturation
Conditions
Brief summary
To examine pulse rate and blood oxygen saturation accuracy of the Nellcor™ Investigational Device during non-motion and walking motion conditions in a diverse patient population through non-invasive means
Interventions
None listed
Sponsors
Medtronic - MITG
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* Male or female participants ≥18 years of age, and \<75 years of age. * Participant is able to participate for the duration of the study * Participant is willing to sign an informed consent form (ICF) * Participant weighs \> 40kg * Participants must be a non-smoker or not have smoked within 36 hours prior to the study
Exclusion criteria
* Participant self-reported prior injury or trauma to fingers or hands, which in the opinion of the investigator, may change blood flow or vascular supply and affect the ability to test sensors * Physiologic abnormalities that prevent proper application of pulse oximetry sensor * Severe contact allergies that cause a reaction to standard adhesive materials such as those found in medical sensors and electrodes * Individuals of childbearing potential who are self-reported as pregnant, or who are self-reported as trying to get pregnant * Morbid obesity (defined as BMI \> 39.5) * Weight \> 136 kg * Participants who self-report problems of unsteadiness or imbalance issues and/or who are unable to walk on a treadmill without holding onto the handrails * Participant self-reported known heart or cardiovascular conditions such as: * Uncontrolled hypertension (Systolic pressure ≥ 140mmHg or Diastolic pressure \> 90mmHg on 3 consecutive readings day of screening) * Heart arrhythmias other than sinus arrhythmia (Self-reported and/or as identified on ECG day of screening). * History of heart attack, blocked artery, history of myocardial ischemia, angina, myocardial infarction, congestive heart failure, cardiomyopathy, stroke, transient ischemic attack, or carotid artery disease * Participants with self-reported clotting disorders, such as: * History of bleeding disorders or personal history of prolonged bleeding from injury * History of blood clots * Hemophilia * Current use of prescription blood thinner * Participants with other self-reported, known health conditions, such as: * Diabetes * Thyroid disease * Kidney disease / chronic renal impairment * History of seizures (except childhood febrile seizures), epilepsy, or unexplained syncope * Recent history of frequent migraine headaches, as determined medically relevant by the PI * History of head injury, as determined medically relevant by the PI * Cancer / chemotherapy * Sickle cell disease * History of hospital admission or a surgical procedure in the 60 days prior to study enrollment (self-reported) * Participants with any contraindications to protocol specific repositioning techniques * Unwillingness or inability to remove colored nail polish from test digit(s) * Participants who have self-reported health conditions beyond what is captured in the prior
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Accuracy of the investigational device SpO2 as compared to the reference device SpO2 | From enrollment to study exit, 1.5 hours |
| Accuracy of the investigational device pulse rate as compared to the reference device pulse rate. | From enrollment to study exit, 1.5 hours |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of the time under evaluation that the NellcorTM Investigational Device provides a SpO2 and PR reading | From enrollment to study exit, 1.5 hours |
Contacts
CONTACTHannah Bowman
CONTACTAmi Stuart
Outcome results
None listed