None listed
Conditions
Interventions
Intervention1: Pulse Oximeter (MD300C20): A non invasive device which measures SpO2 levels in blood
Intervention2: Pulse Oximeter (MD300CI218): A non invasive device which measures SpO2 levels in bloo
Sponsors
Choicemmed Technology India Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male and female participants aged equal to or more than 18 years and equal to or less than 50 years at the time of consent. 2. Participants who can and are willing to provide Informed Consent. 3. Participants who understand and are willing to participate in the clinical study and can comply with CIP requirements. 4. Participants that are non-smokers. 5. Participants having dark pigmentation (Type IV -VI on Fitzpatrick pigmentation scale) 6. Presence of both normal upper limbs.
Exclusion criteria
Exclusion criteria: 1. Participants less than 18 years or more than 50 years of age. 2.Participants considered as being morbidly obese (defined as BMI more than 39.5). 3.Participants with 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. 4.(Note: Certain malformations may still allow to participate if the condition is noted and would not affect the particular sites utilized.) 5.Having recent medical tests done that included an injection of dyes, Magnetic resonance imaging (MRI) or Computed Tomography (CT) environment. 6.Female participants of childbearing potential having positive UPT at the time of screening. 7.Nursing female participants. 8.Participants with known respiratory conditions such as: (self-reported/ clinical history) a.Uncontrolled / severe asthma b.Flu c.Pneumonia / bronchitis d.Shortness of breath / respiratory distress e.Unresolved respiratory or lung surgery with continued indications of health issues f.Emphysema, COPD, lung disease 9.Participants with known heart or cardiovascular conditions such as: (self-reported/ clinical history, except for blood pressure and ECG review) a.Hypertension: systolic >140mmHg, Diastolic >90mmHg on 3 consecutive readings (reviewed during health screen). b.Have had cardiovascular surgery c.Chest pain (angina) d.Heart rhythms other than a normal sinus rhythm or with respiratory sinus arrhythmia (reviewed during health screen) e.Previous heart attack f.Blocked artery g.Unexplained shortness of breath h.Congestive heart failure (CHF) i.History of stroke j.Transient ischemic attack k.Carotid artery disease l.Myocardial ischemia m.Myocardial infarction n.Cardiomyopathy 10.Participants with following health conditions (self-reported/ clinical history) a.Diabetes b.Uncontrolled thyroid disease c.Kidney disease / chronic renal impairment d.History of seizures (except childhood febrile seizures) e.Epilepsy f.History of unexplained syncope g.Recent history of frequent migraine headaches h.Recent symptomatic head injury (within the last 2 months) i.Cancer / chemotherapy 11.Participants with known clotting disorders (self-reported/ clinical history) a. a.History of bleeding disorders or personal history of prolonged bleeding from injury b.History of blood clots c.Hemophilia d.Current use of blood thinner: prescription or daily use of aspirin 12.Participants with severe contact allergies (self-reported/ clinical history) to standard adhesives, latex or other materials found in pulse oximetry sensors. 13.Participants having failure of the Perfusion Index Ulnar/Ulnar+Radial Ratio test (Ratio less than 0.4) 14.Participants having unwillingness or inability to remove colored nail polish from test digits/ fingers. 15.Participants with any other condition, which as per the investigator would jeopardize the outcome of the trial. 16.Participants who are not willing to follow study procedures.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Accuracy of pulse-oximeters SpO2 measurements versus arterial blood co-oximetry (SaO2). The Accuracy Root Mean Square (ARMS) performance of the investigational Pulse Oximeter will meet a specification of 3 or lower in non-motion conditions for the range of 70 - 100% SaO2.Timepoint: 1 day | — |
Secondary
| Measure | Time frame |
|---|---|
| Not ApplicableTimepoint: Not Applicable | — |
Countries
India
Contacts
Public ContactMr Sohal Pendse
ProRelix Services LLP
Outcome results
None listed