SpO2 Accuracy Validation of the OxySoft Sensor Via Reference CO-Oximetry Motion Study

NCT ID: NCT04559763

Last Updated: 2020-10-22

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 16 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-08-18
• Study Completion Date: 2020-08-21

Brief Summary

SpO2 (oxygen saturation) and pulse rate accuracy of pulse oximetry equipment, OxySoft Sensor/N-600x and OxySoft Sensor/N-395, continuous measure of arterial oxygen saturation during hypoxic state throughout motion and non-motion conditions under one system configuration.

The purpose of this Non-Randomized, Prospective,Observational study is to conduct a hypoxia study to directly compare a prototype OxySoft pulse oximeter system to arterial oxygen saturation.

Detailed Description

The study utilizes a single-site, physiology laboratory for non-randomized, prospective, interventional studies. The goal is to enroll a range of twelve (12) to sixteen (16) healthy adult volunteers. Subjects may be of any race,ranging in pigmentation from light to dark to meet the study design requirements.

The general purpose of Invasive Controlled Desaturation Studies during motion is to validate the SpO2and pulse rate accuracy in comparison to reference-standard measurements of blood SaO2 by a CO-oximeter during motion conditions. This is achieved through paired observations of SpO2 and SaO2values over the specified SpO2 accuracy range of 70 % to 100 % SaO2 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. Arterial blood samples are periodically taken from an indwelling arterial catheter for use in the comparison.

Pulse rate accuracy will be evaluated during the same data collection period as SpO2. Pulse rate will be compared to reference ECG heart rate.In the unlikely event that the ECG monitor malfunctions, the Pulse rate reference may be taken using the average pulse rate value from the transfer standard pulse oximeters. This study is designed to support an FDA submission for pulse rate and saturation accuracy in a diverse subject population during motion conditions over a specified saturation range for the Oxysoft pulse oximetry system.

The FDA Guidance Document for Pulse Oximeters and ISO 80601-2-61 define the accepted guideline for evaluation and documenting the SpO2 accuracy in humans. The OxySoft sensor is not FDA approved for the intended study population, healthy adults. To support the development of Nellcor pulse oximeter systems, data is required to test the performance of the sensors with pulse oximetry systems in the adult patient population. In order to accurately validate sensors, manipulation of oxygen and nitrogen levels through the administration of oxygen and nitrogen gas will occur. Measurements of SpO2and pulse rate accuracy in comparison to reference-standard measurements of blood SaO2 by a CO-oximeter during motion and non-motion conditions will be taken and analyzed to support development of Nellcor technology and support FDA submission.

Conditions

Hypoxia; Desaturation of Blood

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

Healthy Adult Volunteers

Non-Invasive Controlled Hypoxia

Intervention Type: DEVICE

Following arterial cannulation, hypoxia is induced by reducing the percent of inspired oxygen the subject breathes while simultaneous measurements are recorded from the test pulse oximeters and arterial blood samples are collected at targeted levels of saturation.

Introduction of Motion conditions: tapping or rubbing

Intervention Type: OTHER

Standard motions include tapping or rubbing at periodic intervals with amplitudes of 1-2 cm and 1-4 Hz with a random variation in frequency will occur at each plateau. Each plateau will have both an interval of tapping and rubbing. Signals are recorded by a validated, computerized data acquisition system (CAS). The device values are sampled once per second and averaged over the time taken to draw the blood sample, taking into account circulation time delays and differences in device response times

Interventions

Non-Invasive Controlled Hypoxia

Following arterial cannulation, hypoxia is induced by reducing the percent of inspired oxygen the subject breathes while simultaneous measurements are recorded from the test pulse oximeters and arterial blood samples are collected at targeted levels of saturation.

Intervention Type: DEVICE

Introduction of Motion conditions: tapping or rubbing

Standard motions include tapping or rubbing at periodic intervals with amplitudes of 1-2 cm and 1-4 Hz with a random variation in frequency will occur at each plateau. Each plateau will have both an interval of tapping and rubbing. Signals are recorded by a validated, computerized data acquisition system (CAS). The device values are sampled once per second and averaged over the time taken to draw the blood sample, taking into account circulation time delays and differences in device response times

Intervention Type: OTHER

Other Intervention Names

Desaturation; Blood Sampling

Eligibility Criteria

Inclusion Criteria

1. Subject must have the ability to understand and provide written informed consent

2. Adult subjects 18 to 50 years of age.

3. Subject must be willing and able to comply with study procedures and duration.

4. Subject is a non-smoker or who has not smoked within 2 days prior to the study.

5. Male or female of any race.

6. Cleared same day Health Assessment form and health screening.

7. Subject demographics include a range of skin pigmentations, including at least 2 darkly pigmented subjects or 15% of the subject pool, whichever is larger.

8. Successful Perfusion Index Ulnar/Ulnar+Radial Ratio test showing adequate collateral blood flow.

Exclusion Criteria

Subjects who meet any of the following criteria will be excluded from the study:

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,

3. pneumonia / bronchitis,

4. shortness of breath / respiratory distress,

5. unresolved respiratory or lung surgery,

6. emphysema, COPD, lung disease

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

5. with respiratory sinus arrhythmia

6. previous heart attack

7. blocked artery

8. unexplained shortness of breath

9. congestive heart failure (CHF)

10. history of stroke

11. transient ischemic attack

12. carotid artery disease

13. myocardial ischemia

14. myocardial infarction

15. cardiomyopathy

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. Subjects with known clotting disorders

10. history of bleeding disorders or personal history of prolonged bleeding from injury

11. history of blood clots

12. hemophilia

13. current use of blood thinner: prescription or daily use of aspirin

14. 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

15. Subjects with prior or known severe allergies to lidocaine (or similar pharmacological agents, e.g. Novocain) or heparin

16. Arterial cannulation within the last 30 days prior to study date, (this may exclude only one radial artery site. left or right)

17. History of clinically significant complications from previous arterial cannulation.

18. A radial artery with ten or more arterial cannulations right or left, excludes that site.

19. Unwillingness or inability to remove colored nail polish or colored artificial nails other than clear from test digits.

20. Other known health condition, should be considered upon disclosure in Health Assessment form

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Medtronic - MITG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Arthur Cabrera, MD

Role: PRINCIPAL_INVESTIGATOR

Clinimark, LLC

Locations

Clinimark

Louisville, Colorado, United States

Countries

United States

Other Identifiers

MDT20006OXYVMT

Identifier Type: -

Identifier Source: org_study_id