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

NCT04559763 | Completed FDA Device

• 1 other identifier: MDT20006OXYVMT
• Study Type: observational
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypoxia; Desaturation of Blood

Keywords

Oxygen Saturation; Invasive Controlled Desaturation

Outcome Measures

Primary Outcomes (2)

• To investigate performance of the OxySoft device by measuring oxygen saturation accuracy during motion and non-motion conditions

  The primary objective of the study is to investigate the efficacy and performance of the OxySoft device by measuring oxygen saturation accuracy in a diverse subject population during motion and non-motion conditions and over a specified saturation range. The acceptance criteria for SpO2, on the non-motion hand, across the saturation range of 70-100% when paired with the N-395: SpO2 OxySoft Sensor/N-395 ± 3% (Arms) The acceptance criteria for SpO2 during motion conditions, on the motion hand, across the saturation range of 70-100% when paired with the N-600x: SpO2 OxySoft Sensor/N-600x ± 3% (Arms)

  October 2020

• To investigate efficacy and performance of OxySoft device by measuring pulse rate accuracy during motion and non-motion conditions

  The secondary objective of the study is to investigate the efficacy and performance of the OxySoft device by measuring pulse rate accuracy in a diverse subject population during motion and non-motion conditions and over a specified saturation range. The acceptance criteria for pulse rate during motion conditions, on the motion hand, across the saturation range of 70-100% when paired with the N-600x: PR OxySoft Sensor/N-600x ≤ 5 BPM

  October 2020

Study Arms (1)

Healthy Adult Volunteers

Device: Non-Invasive Controlled Hypoxia; Other: Introduction of Motion conditions: tapping or rubbing

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

Healthy Adult Volunteers

Introduction of Motion conditions: tapping or rubbing 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

Healthy Adult Volunteers

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 will be a minimum of twelve subjects, ranging in pigmentation from light to dark to skin tones including subjects with deep pigmentation and the subject selection will be an equitable distribution of males and females.

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.
• Subject demographics include a range of skin pigmentations, including at least 2 darkly pigmented subjects or 15% of the subject pool, whichever is larger.
• Successful Perfusion Index Ulnar/Ulnar+Radial Ratio test showing adequate collateral blood flow.

You may not qualify if:

• Subjects who meet any of the following criteria will be excluded from the study:
• 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,
• 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 14, 2020
• First Posted: September 23, 2020
• Study Start: August 18, 2020
• Primary Completion: August 21, 2020
• Study Completion: August 21, 2020
• Last Updated: October 22, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)