SpO2 Accuracy Comparison of Medline ReNewal Sensors to Arterial Blood CO-Oximetry

NCT03565679 | Completed Results FDA Device

• 1 other identifier: PR 2018-268
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this clinical study is to validate the SpO2 accuracy of the Medline ReNewal pulse oximetry sensors during non-motion conditions over the range of 70-100% SaO2 as compared to arterial blood samples assessed by CO-Oximetry. The end goal is to provide supporting documentation for the SpO2 accuracy validation of the ReNewal sensors. It is required that the Accuracy Root Mean Square (ARMS) performance of the ReNewal pulse oximetry sensors will meet a specification of 3 or better in non-motion conditions for the range of 70 - 100% SaO2 thereby demonstrating an acceptable SpO2 accuracy performance specification.

Conditions

Arterial Oxygen Saturation; Healthy

Outcome Measures

Primary Outcomes (1)

• SpO2 Percentage Specification

  Percentage of SpO2 (oxygen saturation by pulse oximetry) measured by the Reprocessed Oximeter pulse oximetry sensors during non-motion conditions over the range of 70-100% SaO2 as compared to arterial blood samples assessed by CO-Oximetry. The Accuracy root mean square (ARMS) between measured SpO2 and reference SaO2 (arterial oxygen saturation) must meett the 3% specification for each Medline Renewal Reprocessed pulse oximetry sensor style.

  2 hours

Study Arms (2)

Masimo SpO2 Adhesive Sensors, Adtx (1859) & (2329)

EXPERIMENTAL

Reference sensors from the reprocessed oximeter device will be placed on each subject to evaluate the SpO2 accuracy and performance.

Device: MEDLINE RENEWAL PULSE OXIMETRY SENSORS

Covidien Nellcor SpO2 Sensor, MAX-A and MAX-N

SHAM COMPARATOR

A whole blood analyzer (CO-Oximeter) is used as the reference standard device for obtaining the functional SaO2 value from arterial blood samples obtained during the study.

Device: CO-OXIMETRY SENSORS

Interventions

MEDLINE RENEWAL PULSE OXIMETRY SENSORS DEVICE

An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. Pulse oximetry monitoring is considered a standard physiological measurement and is used by clinicians in everyday situations to estimate arterial oxygen saturation. Because an arterial sample of blood is not required to make the measurement, the pulse oximeter can provide non-invasive real time information.

Masimo SpO2 Adhesive Sensors, Adtx (1859) & (2329)

CO-OXIMETRY SENSORS DEVICE

A whole blood analyzer (CO-Oximeter) is used as the reference standard device for obtaining the functional SaO2 value from arterial blood samples obtained during the study.

Covidien Nellcor SpO2 Sensor, MAX-A and MAX-N

Eligibility Criteria

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

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, toes, 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.)
• Females who are pregnant, who are trying to get pregnant, or have a urine test positive for pregnancy on the day of the study
• 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,
• respiratory or lung surgery,
• emphysema, chronic obstructive pulmonary disease (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

• Medline Industries: lead
• Clinimark, LLC: collaborator

Study Sites (1)

Clinimark Desaturation Laboratory, Site ID# 001

Louisville, Colorado, 80027, United States

Location

Results Point of Contact

• Title: Kara Cassady
• Organization: Medline Industries, Inc

kcassady@medline.com

847-643-3809

Study Officials

• Arthur Cabrera, MD

  Avista Adventist Hospital, Staff Anesthesiologist

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Subjects will recline for the study. Reference sensors will be placed on each subject to evaluate the SpO2 accuracy and performance. Shield material may be used between any adjacent finger sensors to prevent optical crosstalk. Simultaneous data collection will be set up for devices under test. The data from the test devices will be collected by the sponsor or trained Clinimark Study staff. Data will be collected for 1 second intervals data analysis. The SpO2 accuracy of the test devices will be evaluated over the oxygen saturation range between 70-100%.

Study Record Dates

• First Submitted: May 9, 2018
• First Posted: June 21, 2018
• Study Start: May 9, 2018
• Primary Completion: May 10, 2018
• Study Completion: May 10, 2018
• Last Updated: June 18, 2019
• Results First Posted: June 10, 2019

Record last verified: 2019-06

Locations

US (1)