Phase
Condition
N/ATreatment
N/AClinical Study ID
Ages 18-39 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
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
Exclusion
Exclusion Criteria:
Subject is considered as being morbidly obese (defined as BMI >39.5)
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)
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 sinusarrhythmia, 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
cardiomyopathy
implantable active medical device such as pacemaker or automatic defibrillator
Self-reported health conditions as identified in the Health Assessment Form
diabetes
uncontrolled thyroid disease
kidney disease / chronic renal impairment
history of seizures (except childhood febrile seizures)
epilepsy
history of unexplained syncope
recent history of frequent migraine headaches
recent symptomatic head injury, within the last 2 months
cancer requiring chemotherapy, radiation, or current treatment
subjects with known clotting disorders
history of bleeding disorders or personal history of prolonged bleeding frominjury
history of blood clots
hemophilia
sickle cell trait or disease
current use of blood thinner: prescription or daily use such as aspirin
subjects with Severe contact allergies to standard adhesives, latex or othermaterials found in pulse oximetry sensors, ECG electrodes, respiration monitorelectrodes or other medical sensors
participants with severe allergy to iodine (only applicable if iodine is used)
subjects with prior or known severe allergies to lidocaine (or similarpharmacological agents, e.g. Novocain) or heparin
arterial cannulation within the last 30 days prior to study date, (this mayexclude only one radial artery site, left or right)
history of clinically significant complications from previous arterialcannulation
unwillingness or inability to remove colored nail polish or colored artificialnails other than clear from test digits
other known health condition, upon disclosure in Health Assessment form
Study Design
Study Description
Connect with a study center
Medtronic Clinical Physiology Lab
Denver, Colorado 80218
United StatesActive - Recruiting
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