OM2 Motion Verification Study

Verification of Investigational Pulse Oximetry Devices During Motion and Non-Motion Conditions in Adult Volunteers

The verification of an investigational pulse oximetry board to verify pulse rate and saturation accuracy over a specified saturation range in diverse populations.

Study Overview

• Status: Completed
• Conditions: Hypoxia

Detailed Description

To verify the SpO2 and pulse rate accuracy in comparison to reference-standard blood measurements during motion and non-motion conditions. To achieve paired observations of SpO2 and SaO2 values over the specified SpO2 accuracy range of the prototype pulse oximeter on a group of healthy adult volunteers. The fraction of inspired oxygen (FiO2) delivered to test subjects is varied to achieve a series of targeted steady-state saturation periods. In this study, the investigational pulse oximetry PCBA system saturation measurements will be compared to saturation measurements made by a multi-wavelength CO-oximeter, taken from arterial blood samples from a diverse pool of healthy human subjects.

• Study Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Louisville, Colorado, United States, 80027
      • Element

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Healthy Male or Female volunteers age 18 to 50 years, weighing greater than 40kgs. Volunteers must be non-smokers or not smoked within 2 days prior to the study. Cleared a same day health assessment form and health screen to ensure none of the exclusion criteria was met. With a successful perfusion index ulnar/ulnar+radial ratio test showing adequate collateral blood flow.

Description

Inclusion Criteria:

1. Male or female subjects 18 to 50 years of age
2. Subject is willing and able to comply with study procedures and duration
3. Subject is willing to sign an informed consent
4. Subject weighs >40kg
5. Subject is a non-smoker or has not smoked within 2 days prior to the study
6. Cleared same day health assessment form and health screening
7. Successful perfusion index ulnar/ulnar+radial ratio test showing adequate collateral blood flow.

Exclusion Criteria:

1. Subject is considered as being morbidly obese (defined as BMI >39.5)
2. 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)
3. 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
4. Subjects with COHb levels >3% as assessed by CO-Oximetry during the procedure
5. tHb < 10 g/dl as assessed by CO-Oximetry during the procedure
6. MetHb ≥ 2% as assessed by CO-Oximetry during the procedure

7. Subjects with known respiratory conditions such as:

   1. uncontrolled / severe asthma
   2. flu or influenza type infection
   3. pneumonia / bronchitis
   4. shortness of breath / respiratory distress
   5. unresolved respiratory or lung surgery
   6. emphysema, COPD, lung disease
   7. recent COVID (last 2 months)

8. Subjects with known heart or cardiovascular conditions such as:

   1. hypertension: systolic >140mmHg, or Diastolic >90mmHg on 3 consecutive readings
   2. have had cardiovascular surgery
   3. chest pain (angina)
   4. heart rhythms other than a normal sinus rhythm or with respiratory sinus arrhythmia (reviewed during health screen)
   5. previous heart attack
   6. blocked artery
   7. unexplained shortness of breath
   8. congestive heart failure (CHF)
   9. history of stroke
   10. transient ischemic attack
   11. carotid artery disease
   12. myocardial ischemia
   13. myocardial infarction
   14. cardiomyopathy
   15. implantable active medical device such as pacemaker or automatic defibrillator

9. Self-reported health conditions as identified in the Health Assessment Form

   1. diabetes
   2. uncontrolled thyroid disease
   3. kidney disease / chronic renal impairment
   4. history of seizures (except childhood febrile seizures)
   5. epilepsy
   6. history of unexplained syncope
   7. recent history of frequent migraine headaches
   8. recent symptomatic head injury, within the last 2 months
   9. cancer requiring chemotherapy, radiation, or current treatment
   10. subjects with known clotting disorders
   11. history of bleeding disorders or personal history of prolonged bleeding from injury
   12. history of blood clots
   13. hemophilia
   14. sickle cell trait or disease
   15. current use of blood thinner: prescription or daily use of aspirin
   16. 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
   17. participants with severe allergy to iodine (only applicable if iodine is used)
   18. subjects with prior or known severe allergies to lidocaine (or similar pharmacological agents, e.g. Novocain) or heparin
   19. arterial cannulation within the last 30 days prior to study date, (this may exclude only one radial artery site, left or right)
   20. history of clinically significant complications from previous arterial cannulation
   21. unwillingness or inability to remove colored nail polish or colored artificial nails other than clear from test digits
   22. other known health condition, upon disclosure in Health Assessment form

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Healthy Volunteers

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Verification of saturation accuracy during motion and non-motion conditions	Saturation accuracy in a diverse subject population over a specified saturation range during motion and non-motion conditions. The acceptance criteria for the Nellcor™ Pro 7 Pulse Oximetry PCBA are as follows: The acceptance criteria for SpO2 during motion and non-motion conditions across the saturation range of 70-100%: Motion: SpO2 Max-A ±3% (ARMS) Max-N ±3% (ARMS) OxySoft-N ±3% (ARMS) Non-Motion: SpO2 SC-A ±2 % (ARMS)	2.5 hours
Verification of Pulse Rate during motion and non-motion conditions	The acceptance criteria for pulse rate during motion and non-motion conditions from 20-250 BPM over a specified saturation range of 70-100%: Motion: Pulse Rate Max-A ≤5% BPM (ARMS) Max-N ≤5% BPM (ARMS) OxySoft-N ≤5% BPM (ARMS) Non-Motion: Pulse Rate SC-A ≤3% BPM (ARMS)	2.5 hours

Collaborators and Investigators

• Sponsor: Medtronic - MITG
• Investigators: Principal Investigator: Monica Rabanal, Element Labs

Study record dates

Study Major Dates

• Study Start (Actual): March 7, 2024
• Primary Completion (Actual): March 27, 2024
• Study Completion (Actual): March 27, 2024

Study Registration Dates

• First Submitted: April 24, 2024
• First Submitted That Met QC Criteria: May 14, 2024
• First Posted (Actual): May 16, 2024

Study Record Updates

• Last Update Posted (Actual): May 16, 2024
• Last Update Submitted That Met QC Criteria: May 14, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Respiratory; Hypoxia
• Other Study ID Numbers: MDT23026OM2VMT

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No