OM2 Low Saturation Verification

Last updated: February 27, 2025
Sponsor: Medtronic - MITG
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT06661889
MDT23028OM2VLS
  • Ages 18-39
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

The verification of an investigational pulse oximetry board to verify pulse rate and saturation accuracy over a specified saturation range in diverse populations.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Healthy volunteers 18 to ≤39 years

  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 2 days prior to the study

  6. Cleared same day health assessment form and health screening

Exclusion

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 orforehead/skull or other sensor sites which would limit the ability to test sitesneeded for the study (Note: Certain malformations may still allow subjects toparticipate if the condition is noted and would not affect the sites utilized)

  3. Subjects 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 known concurrent, active respiratory conditions such as:

  5. uncontrolled / severe asthma

  6. flu or influenza type infection

  7. pneumonia / bronchitis

  8. shortness of breath / respiratory distress

  9. unresolved respiratory or lung surgery

  10. emphysema, COPD, lung disease

  11. recent COVID (last 2 months)

  12. Subjects with known heart or cardiovascular conditions such as:

  13. hypertension: systolic >140mmHg, or Diastolic >90mmHg on 3 consecutive readings

  14. have had cardiovascular surgery

  15. chest pain (angina)

  16. heart rhythms other than a normal sinus rhythm and/or with respiratory sinusarrhythmia, at the discretion of the Principal Investigator or designee

  17. previous heart attack

  18. blocked artery

  19. unexplained shortness of breath

  20. congestive heart failure (CHF)

  21. history of stroke

  22. transient ischemic attack

  23. carotid artery disease

  24. myocardial ischemia

  25. myocardial infarction

  26. cardiomyopathy

  27. implantable active medical device such as pacemaker or automatic defibrillator

  28. Self-reported health conditions as identified in the Health Assessment Form

  29. diabetes

  30. uncontrolled thyroid disease

  31. kidney disease / chronic renal impairment

  32. history of seizures (except childhood febrile seizures)

  33. epilepsy

  34. history of unexplained syncope

  35. recent history of frequent migraine headaches

  36. recent symptomatic head injury, within the last 2 months

  37. cancer requiring chemotherapy, radiation, or current treatment

  38. subjects with known clotting disorders

  39. history of bleeding disorders or personal history of prolonged bleeding frominjury

  40. history of blood clots

  41. hemophilia

  42. sickle cell trait or disease

  43. current use of blood thinner: prescription or daily use such as aspirin

  44. subjects with Severe contact allergies to standard adhesives, latex or othermaterials found in pulse oximetry sensors, ECG electrodes, respiration monitorelectrodes or other medical sensors

  45. participants with severe allergy to iodine (only applicable if iodine is used)

  46. subjects with prior or known severe allergies to lidocaine (or similarpharmacological agents, e.g. Novocain) or heparin

  47. arterial cannulation within the last 30 days prior to study date, (this mayexclude only one radial artery site, left or right)

  48. history of clinically significant complications from previous arterialcannulation

  49. unwillingness or inability to remove colored nail polish or colored artificialnails other than clear from test digits

  50. other known health condition, upon disclosure in Health Assessment form

Study Design

Total Participants: 24
Study Start date:
November 18, 2024
Estimated Completion Date:
March 31, 2025

Study Description

To verify the SpO2 and pulse rate accuracy in comparison to a reference standard blood measurements. To achieve paired observations of SpO2 and SaO2 values over the specified SpO2 accuracy range of the prototype pulse oximeter on a group of healthy adult volunteers. The fraction of inspired oxygen (FiO2) delivered to test subjects is varied to achieve a series of targeted steadystate saturation periods. In this study, the investigational pulse oximetry PCBA system saturation measurements will be compared to saturation measurements made by a multi-wavelength CO-oximeter, taken from arterial blood samples from a diverse pool of healthy human subjects.

Connect with a study center

  • Medtronic Clinical Physiology Lab

    Denver, Colorado 80218
    United States

    Active - Recruiting

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