Nellcor Device Sitting-Walking Test for Pulse Oximetry

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study evaluates the accuracy of the Nellcor Investigational Device for measuring pulse rate and oxygen saturation in adults during non-movement and walking. It uses non-invasive sensors across a diverse patient population to compare readings under different activity conditions. Enrollment includes adults 18 to under 75 who meet weight and health criteria and can consent. The study is conducted at a clinical physiology lab in Denver, with Medtronic as lead sponsor. Results may inform device performance in real-world use cases involving mobility.

Why it matters

Who can join: the full rules

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 exclusion criteria, which in the opinion of the Investigator and/or Clinical Staff would classify the participant as medically unsuitable

Where it's running

• Clinical Physiology Lab
  Denver, Colorado, United States Recruiting

Study contacts

• Study coordinator: Hannah Bowman
• Email: Hannah.bowman@medtronic.com
• Phone: 720-930-1695

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.