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Recruiting NCT07234279

Nellcor™ Investigational Device Sitting-Walking Study

Conditions: Oxygen Saturation

Sex: All
Ages: 18 Years – 75 Years
Healthy volunteers: Yes
Enrollment: 30
Sponsor: Medtronic - MITG

Location: Clinical Physiology Lab Denver Colorado

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

Eligibility Criteria

Inclusion Criteria: * Male or female participants ≥18 years of age, and \ 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 exclusion criteria, which in the opinion of the Investigator and/or Clinical Staff would classify the participant as medically unsuitable

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07234279). StuddyBuddy aggregates publicly available trial information.