Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:57 AM
Ignite Modification Date:
2025-12-25 @ 4:57 AM
NCT ID:
NCT03918018
Eligibility Criteria:
Inclusion Criteria:
* 10-15 Adults with a minimum of 3 males and a minimum of 3 females, with the balance made up of either
* Subject must have the ability to understand and provide written informed consent
* Subject is 18 to 50 years of age
* Subject must be willing and able to comply with study procedures and duration
* Subject is a non-smoker or who has not smoked within 2 days prior to the study
* Wrist size should be between 15-23 cm (5.9 - 9 inches)
Exclusion Criteria:
* Subject is considered as being morbidly obese (defined as BMI \>39.5)
* Compromised circulation, injury, or physical malformation of fingers, wrist, 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 particular sites utilized.)
* Female subjects that are actively trying to get pregnant or are pregnant (confirmed by positive urine pregnancy test unless the subject is known to be not of child-bearing potential).
* Smoker Subjects who have refrained will be screened for COHb levels \>3% as assessed with a Masimo Radical 7 (Rainbow)
* Subjects with known respiratory conditions such as: (self-reported)
* uncontrolled / severe asthma,
* flu,
* pneumonia / bronchitis,
* shortness of breath / respiratory distress,
* unresolved respiratory or lung surgery with continued indications of health issues ,
* emphysema, COPD, lung disease
* Subjects with known heart or cardiovascular conditions such as: (self-reported, except for blood pressure and ECG review)
* hypertension: systolic \>140mmHg, Diastolic \>90mmHg on 3 consecutive readings (reviewed during health screen).
* have had cardiovascular surgery
* Chest pain (angina)
* heart rhythms other than a normal sinus rhythm or with respiratory sinus arrhythmia (reviewed during health screen)
* 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
* Self-reported health conditions as identified in the Health Assessment Form (self-reported)
* 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 / chemotherapy
* Subjects with known clotting disorders (self-reported)
* history of bleeding disorders or personal history of prolonged bleeding from injury
* history of blood clots
* hemophilia
* current use of blood thinner: prescription or daily use of aspirin
* Subjects with severe contact allergies to standard adhesives, latex or other materials found in pulse oximetry sensors, ECG electrodes, respiration monitor electrodes or other medical sensors (self-reported)
* Subjects with severe allergies to iodine (only applicable if iodine is used)
* Subjects with severe allergies to lidocaine (or similar pharmacological agents, e.g. Novocaine)
* Failure of the Perfusion Index Ulnar/Ulnar+Radial Ratio test (Ratio \< 0.4)
* Unwillingness or inability to remove colored nail polish from test digits.
* Other known health condition, should be considered upon disclosure in health assessment form
* Wrist size should be between 15-23 cm (5.9 - 9 inches)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT03918018
Study Brief:
Protocol Section:
NCT03918018