N600X Low Saturation Accuracy Validation

NCT05532670 | Completed FDA Device

• 1 other identifier: MDT22013LSOXMN
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hypoxia

Keywords

Oxygen Saturation; Invasive Controlled Desaturation; Pulse Oximetry; Desaturation of Blood

Outcome Measures

Primary Outcomes (2)

• 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

Interventions

Non-Invasive Controlled Hypoxia 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.

Also known as: Desaturation, Blood Sampling

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• \. 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.
• \. Any gender 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.

You may not qualify if:

• Subject with sickle cell disease.
• 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:

Sponsors & Collaborators

• Medtronic - MITG: lead

Study Sites (1)

Clinimark

Louisville, Colorado, 80027, United States

Location

MeSH Terms

Conditions

Hypoxia

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Arthur Cabrera, MD

  Clinimark, LLC

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: August 31, 2022
• First Posted: September 8, 2022
• Study Start: September 29, 2022
• Primary Completion: October 7, 2022
• Study Completion: November 1, 2022
• Last Updated: November 23, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)