SpO2 Accuracy Low Saturation Validation of the OxySoftN Sensor

NCT04811963 | Completed FDA Device

• 1 other identifier: MDT20028OXYLOV
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

To compare prototype pulse oximeter 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; Desaturation of Blood

Keywords

Oxygen Saturation; Invasive Controlled Desaturation

Outcome Measures

Primary Outcomes (1)

• To investigate performance of the OxySoft device by measuring oxygen saturation accuracy over a Low Saturation range of 60-80%

  To validate the proposed claims for saturation accuracy in a diverse subject population during Low Saturation over a specified saturation range. The acceptance criteria for the OxySoftN Sensor SpO2 during Low Saturation conditions across the saturation range of 60-80% when paired with the N-600x, PM1000N and Oxicable: SpO2 OxySoftN ± 3% (Arms)

  April 2021

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: Probability Sample

Study Population

The study population includes a minimum of ten healthy non-smoking (or has refrained from smoking for 2 days) competent adults 18-50 years of age. The subject selection will be an equitable distribution of males and females of any race with at least 2 darkly pigmented subjects or 15% of the subject pool, whichever is larger.

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.
• Male or female 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 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:
• Hypertension: systolic \>140mmHg, or Diastolic \>90mmHg on 3 consecutive readings.

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: March 12, 2021
• First Posted: March 23, 2021
• Study Start: April 6, 2021
• Primary Completion: April 9, 2021
• Study Completion: April 9, 2021
• Last Updated: May 18, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)