Not yet recruiting NCT07234279
Nellcor™ Investigational Device Sitting-Walking Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Oxygen Saturation. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Feasibility of the Investigational Nellcor™ Investigational Device During Non-Motion and Walking Motion Conditions in Adult Volunteers
Overview
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
Primary outcome measures
- Accuracy of the investigational device SpO2 as compared to the reference device SpO2 [Time frame: From enrollment to study exit, 1.5 hours]
- Accuracy of the investigational device pulse rate as compared to the reference device pulse rate. [Time frame: From enrollment to study exit, 1.5 hours]
Secondary outcome measures (1)
- Percentage of the time under evaluation that the NellcorTM Investigational Device provides a SpO2 and PR reading [Time frame: From enrollment to study exit, 1.5 hours]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07234279 · MDT25003NPDSWF