OM2 Low Saturation Verification
Completed
Conditions studied: Hypoxia
In brief
The verification of an investigational pulse oximetry board to verify pulse rate and saturation accuracy over a specified saturation range in diverse populations.
Key facts
- Study ID
- NCT06661889
- Run by
- Medtronic - MITG
- People needed
- 28
- Starts
- 2024-11-18
- Expected to finish
- 2025-05-27
- Last updated by the study team
- 2026-05-14
Who can join
Age: 18 and older, up to 39. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Healthy volunteers 18 to ≤39 years
- Subject is willing and able to comply with study procedures and duration
- Subject is willing to sign an informed consent
- Subject weighs >40kg
- Subject is a non-smoker or has not smoked within 2 days prior to the study
- Cleared same day health assessment form and health screening
You may not qualify if…
- Subject is considered as being morbidly obese (defined as BMI >39.5)
- Compromised circulation, injury, or physical malformation of fingers, hands, ears or forehead/skull or other sensor sites which would limit the ability to test sites needed for the study (Note: Certain malformations may still allow subjects to participate if the condition is noted and would not affect the sites utilized)
- 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
- Subjects with known concurrent, active respiratory conditions such as:
- uncontrolled / severe asthma
- flu or influenza type infection
- pneumonia / bronchitis
- shortness of breath / respiratory distress
- unresolved respiratory or lung surgery
- emphysema, COPD, lung disease
- recent COVID (last 2 months)
- Subjects with known heart or cardiovascular conditions such as:
- hypertension: systolic >140mmHg, or Diastolic >90mmHg on 3 consecutive readings
- have had cardiovascular surgery
- chest pain (angina)
- heart rhythms other than a normal sinus rhythm and/or with respiratory sinus arrhythmia, at the discretion of the Principal Investigator or designee
- previous heart attack
- blocked artery
- unexplained shortness of breath
- congestive heart failure (CHF)
- history of stroke
- transient ischemic attack
- carotid artery disease
- myocardial ischemia
- myocardial infarction
Where it is running
- Medtronic Clinical Physiology Lab — Denver, Colorado, United States
Full record on ClinicalTrials.gov
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