N600X Low Saturation Accuracy Validation

SpO2 Accuracy Validation of N600x Sensors Via Reference CO-Oximetry in Healthy, Well-Perfused Subjects

To compare pulse oximetry saturation measurements, during normal to low saturation, to saturation measurements made by a multi-wavelength CO-oximeter, taken from arterial blood samples from healthy human subjects.

Study Overview

• Status: Completed
• Conditions: Hypoxia
• Intervention / Treatment: Device: Non-Invasive Controlled Hypoxia

Detailed Description

The study utilizes a single-site, physiology laboratory (Clinimark) to conduct this Post Market, non-randomized, prospective studies. The goal is to enroll a minimum of fifteen subjects. Subject pool goal of diversity across ethnicity, race and sex of varying skin tones to meet the study design requirements.

The general purpose of Invasive Controlled Desaturation Studies is to support the SpO2 accuracy of the post market pulse oximetry sensors and paired monitor in comparison to reference-standard measurements of blood SaO2 by a CO-oximeter during low saturation conditions. This is achieved through paired observations of SpO2 and SaO2 values over the specified SpO2 accuracy range of 60% to 100% SaO2 of the 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.

• Study Type: Observational
• Enrollment (Actual): 15

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Louisville, Colorado, United States, 80027
      • Clinimark

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 46 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Study Population

The study population includes a 15 healthy non-smoking competent adults 18-50 years of age. With an aim of diversity across ethnicity, race and sex of varying skin tones.

Description

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. Any gender of any race.

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

7. 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)

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

Exclusion Criteria:

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

8. 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

9. 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 respiratory sinus arrhythmia
   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

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of pulse rate (BPM) by a pulse oximeter monitor and sensor, compared to ECG pulse rate measurement	To validate the proposed claims for pulse rate (BPM) accuracy in diverse subject population during Low Saturation over a specified saturation ranges.	October 2022
Comparison of SPO2 saturation levels by a pulse oximeter to saturation measurements made by a multi-wavelength CO-oximeter.	To validate the proposed claims for SPO2 saturation accuracy in diverse subject population during Low Saturation over a specified saturation ranges.	October 2022

Collaborators and Investigators

• Sponsor: Medtronic - MITG
• Investigators: Principal Investigator: Arthur Cabrera, MD, Clinimark, LLC

Study record dates

Study Major Dates

• Study Start (Actual): September 29, 2022
• Primary Completion (Actual): October 7, 2022
• Study Completion (Actual): November 1, 2022

Study Registration Dates

• First Submitted: August 31, 2022
• First Submitted That Met QC Criteria: September 6, 2022
• First Posted (Actual): September 8, 2022

Study Record Updates

• Last Update Posted (Actual): November 23, 2022
• Last Update Submitted That Met QC Criteria: November 21, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Pulse Oximetry; Oxygen Saturation; Invasive Controlled Desaturation; Desaturation of Blood
• Additional Relevant MeSH Terms: Signs and Symptoms, Respiratory; Hypoxia
• Other Study ID Numbers: MDT22013LSOXMN

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: All participant data will be analyzed and outlined in final study report. Individual participant data will only be made available to the participant and or participant primary care physician as applicable.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes