SpO2 Validation of Noninvasive Red Diamond Disposable Pulse Oximeter Sensor

NCT03124602 | Completed Results FDA Device

• 1 other identifier: TP18604A_195
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

In this study, the level of oxygen within the blood will be reduced in a controlled manner by reducing the concentration of oxygen the study volunteer breathes. The accuracy of a noninvasive pulse oximeter sensor will be assessed by comparison to the oxygen saturation measurements from a laboratory blood gas analyzer.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Accuracy of Red Diamond Disposable Pulse Oximeter Sensor by Arms Calculation

  Accuracy will be determined by comparing the noninvasive blood oxygen saturation measurement of the pulse oximeter to that obtained from a blood sample and calculating the Accuracy root mean square (ARMS) error value. In order to obtain the Arms value, the blood oxygen saturation measurement form a laboratory pulse Co-Oximeter is subtracted from the pulse oximeter oxygen saturation measurement for a number of samples, the average of this difference is computed as the bias. The standard deviation of the differences is computed as the precision. The square root of the sum of the squares of bias and precision is computed as the ARMS Error value.

  1-5 hours per subject

Study Arms (1)

Test Subject

EXPERIMENTAL

All subjects are enrolled into the test group and all subjects receive the noninvasive Red Diamond Disposable Pulse Oximeter Sensor

Device: Red Diamond Disposable Pulse Oximeter Sensor

Interventions

Red Diamond Disposable Pulse Oximeter Sensor DEVICE

Noninvasive Pulse Oximeter Sensor

Test Subject

Eligibility Criteria

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

You may qualify if:

• Competent non-smoking (smokers including e-cigarette users) adults between the ages of 18 and 50 years of age.
• We may also be interested in specifically recruiting smokers for some portions of this study as well as non-smokers for other portions of this study.
• Must weigh a minimum of 110 lbs and no more than 250 lbs unless subject is over 6 feet tall.
• BMI less than or equal to 35
• Must have a hemoglobin value greater than or equal to 11 g/dL.
• Baseline heart rate 45 bpm to 85 bpm.
• CO value less than or equal to 2.0% FCOHb (unless we are specifically interested in recruiting smokers)
• Physical status of ASA I or II (American Society of Anesthesiology Class 1; Healthy subjects without any systemic disease at all. American Society of Anesthesiology Class II; subjects with mild systemic disease)
• Blood Pressure (Systolic BP less than or equal to 140 mmHg and Diastolic BP less than or equal to 90 mmHg).
• Able to read and communicate in English
• Has signed written informed consent
• Female, non-pregnant.
• Female subjects will be provided with a pregnancy test free of charge.

You may not qualify if:

• Subjects who do not understand the study and the risks involved.
• Subjects with open wounds, lacerations, inflamed tattoos or piercings, visible healing wounds.
• Subjects with frequent or severe headaches and/or migraine headaches.
• Subject has known drug or alcohol abuse. Subjects who uses recreational drugs.
• Subject has experienced a head injury with loss of consciousness within the last year.
• Any chronic bleeding disorders (i.e. hemophilia)
• Any history of a stroke, myocardial infarction, seizures or heart attack.
• Any cancer or history of cancer (not including skin cancer).
• Chronic neurological diseases (i.e. multiple sclerosis, Huntington's Disease).
• Any cardiac dysrhythmias (i.e. atrial fibrillation)(without physicians clearance)
• Subject has known neurological and/or psychiatric disorder (i.e. schizophrenia, bipolar disorder) that interferes with the subjects' level of consciousness.
• Known or concurrent chronic usage of psychoactive or anticonvulsive drugs. Subjects with psychiatric conditions or are on psychiatric medications (i.e. tricyclic antidepressants, MAO inhibitors, Lithium, neuroleptics, anxiolytics or antipsychotics, except SSRIs).
• Subject has any medical condition which in the judgment of the investigator and/or medical staff, renders them ineligible for participation in this study, such as Reynauds Syndrome.
• Subject has Wolff-Parkinson-White Syndrome or Stokes-Adams Syndrome
• Inability to tolerate sitting still or maintain minimal movement for up to 90 minutes.

Sponsors & Collaborators

• Masimo Corporation: lead

Study Sites (1)

Masimo Corporation

Irvine, California, 92618, United States

Location

Results Point of Contact

• Title: Tala Harake
• Organization: Masimo

studies@masimo.com

9492977459

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2017
• First Posted: April 24, 2017
• Study Start: March 7, 2017
• Primary Completion: May 11, 2017
• Study Completion: May 11, 2017
• Last Updated: August 22, 2019
• Results First Posted: August 22, 2019

Record last verified: 2019-08

Locations

US (1)