Status:
COMPLETED
SpO2 Accuracy Low Saturation Validation of the OxySoftN Sensor
Lead Sponsor:
Medtronic - MITG
Conditions:
Hypoxia
Desaturation of Blood
Eligibility:
All Genders
18-50 years
Brief Summary
To compare prototype pulse oximeter saturation measurements, during normal to low saturation, to saturation measurements made by a multi-wavelength CO-oximeter, taken from arterial blood samples from ...
Detailed Description
The study utilizes a single-site, physiology laboratory (Clinimark) for non-randomized, prospective, observational studies. The goal is to enroll a minimum of ten subjects. Subjects may be of any race...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Subject must have the ability to understand and provide written informed consent
- Adult subjects 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.
- Male or female of any race.
- Cleared same day Health Assessment form and health screening.
- Cleared physical exam by a licensed physician, physician assistant, or advanced practice nurse (medical exam includes 12-lead ECG, medical history and blood test to show no sickle cell disease present)
- Successful Perfusion Index Ulnar/Ulnar+Radial Ratio test showing adequate collateral blood flow.
- Exclusion Criteria
- 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.)
- Females 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 COHb levels \>3% as assessed by CO-Oximetry during the procedure
- tHb \< 10 g/dl as assessed by CO-Oximetry during the procedure
- MetHb ≥ 2% as assessed by CO-Oximetry during the procedure
- Subjects with known 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
- 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 or
- with respiratory sinus arrhythmia
- 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
- 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
- Subjects with known clotting disorders
- 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
- Subjects with prior or known severe allergies to lidocaine (or similar pharmacological agents, e.g. Novocain) or heparin
- Arterial cannulation within the last 30 days prior to study date, (this may exclude only one radial artery site. Left or right)
- History of clinically significant complications from previous arterial cannulation.
- A radial artery with ten or more arterial cannulations right or left, excludes that site.
- Unwillingness or inability to remove colored nail polish or colored artificial nails other than clear from test digits.
- Other known health condition, should be considered upon disclosure in Health Assessment form
Exclusion
Key Trial Info
Start Date :
April 6 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 9 2021
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04811963
Start Date
April 6 2021
End Date
April 9 2021
Last Update
May 18 2021
Active Locations (1)
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1
Clinimark
Louisville, Colorado, United States, 80027