Belun SpO2 Accuracy Comparison to Arterial Blood CO-Oximetry

NCT04873947 | Completed FDA Device

• 1 other identifier: PR2020-376
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

This study was a comparative, single-center, non-randomized study conducted to evaluate the SpO2 accuracy per standards and guidelines identified above for SpO2 accuracy for pulse oximetry equipment over the range of 70-100% SaO2 under non-motion conditions. Arterial blood sampling measured by functional SaO2 CO-Oximetry, was used as the basis for comparison. Testing was conducted under normal office environment conditions.

Conditions

Hypoxia

Outcome Measures

Primary Outcomes (2)

• Collect SpO2 data for accuracy statistical analysis by 10 subjects

  Subjects were given medical grade mixtures of oxygen and nitrogen to induce stable plateaus across the range of 100% to 70%. The goal was to have an equal distribution of data by decade. The stable plateaus allowed data collection in the following SaO2 ranges 95-100, 90-95, 85-90, 80-85, 75-80, 70-75. In general, 4 to 8 discrete points were collected at each of the levels.

  3 days

• Accuracy data analysis

  Data analysis follows ISO80601-2-61:2017, Annex EE and Pulse Oximeters - Premarket Notifications Submissions \[510(k)s\] Guidance For Industry and Food and Drug Administration Staff (issued: March 4, 2013).

  3 days

Study Arms (1)

healthy adult volunteer

Subject is 18 to 50 years of age. Subject is a non-smoker or who has not smoked within 2 days prior to the study.

Device: Pulse Oximeter

Interventions

Pulse Oximeter DEVICE

The investigational device will be placed on the finger of the left or right hand per the instructions for use. Simultaneous data collection will be set up for the system under test and control oximeter.

healthy adult volunteer

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The study population will include 10 to 15 healthy non-smoking (or has refrained from smoking for 2 days) competent adults, ages 18 to 50 years. The subject selection will be an equitable distribution of males and females of any race with varying skin tones including at least 2 darkly pigmented subjects or 15% of the subject pool, whichever is larger.

You may qualify if:

• Adults with a minimum of 3 males and a minimum of 3 females, with the balance made up of either
• Subject must have the ability to understand and provide written informed consent
• Subject is 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

You may not qualify if:

• Subject is considered as being morbidly obese (defined as BMI \>39.5)
• 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. (Note: Certain malformations may still allow subjects to participate if the condition is noted and would not affect the particular sites utilized.)
• Female subjects that are actively trying to get pregnant or are pregnant (confirmed by positive urine pregnancy test unless the subject is known to be not of child-bearing potential).
• Smoker Subjects who have refrained will be screened for COHb levels \>3% as assessed with a Masimo Radical 7 (Rainbow)
• Subjects with known respiratory conditions such as: (self-reported)
• uncontrolled / severe asthma,
• flu,
• pneumonia / bronchitis,
• shortness of breath / respiratory distress,
• unresolved respiratory or lung surgery with continued indications of health issues,
• emphysema, COPD, lung disease
• Subjects with known heart or cardiovascular conditions such as: (self-reported, except for blood pressure and ECG review)
• hypertension: systolic \>140mmHg, Diastolic \>90mmHg on 3 consecutive readings (reviewed during health screen).
• have had cardiovascular surgery
• Chest pain (angina)

Sponsors & Collaborators

• Belun Technology Company Limited: lead
• Clinimark, LLC: collaborator

Study Sites (1)

Clinimark, LLC

Louisville, Colorado, 80027, United States

Location

MeSH Terms

Conditions

Hypoxia

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Arthur Cabrera, M.D.

  Clinimark, LLC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2021
• First Posted: May 5, 2021
• Study Start: August 25, 2020
• Primary Completion: August 28, 2020
• Study Completion: August 28, 2020
• Last Updated: May 5, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)