Desaturation Validation of INVSENSOR00012

NCT03435224 | Completed Results FDA Device

• 1 other identifier: TP-19088
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

This study is designed to compare the accuracy of a noninvasive measurement of oxygen saturation compared to reference values obtained by a laboratory blood gas analyzer. Arterial blood samples will be collected from healthy adult subjects while undergoing a desaturation procedure wherein the concentration of oxygen inhaled is slowly reduced until the subject's arterial oxygen concentration is approximately 70%. During the desaturation, the subject's hand and arm without the arterial line will be subjected to motion.After completing the desaturation, the gas mixture will be returned to room air concentrations.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Oxygen Saturation (SpO2) Accuracy of Sensor

  Performance of the sensors will be determined by comparing the noninvasive oxygen saturation measurement (SpO2) of the pulse oximeter sensors to the arterial oxygen saturation (SaO2) value obtained from a reference blood sample and calculating the Arithmetic root mean square (ARMS) value.

  1-5 hours

Study Arms (1)

INVSENSOR00012

EXPERIMENTAL

All subjects consented are enrolled into the test group and will receive the INVSENSOR00012.

Device: INVSENSOR00012

Interventions

INVSENSOR00012 DEVICE

Noninvasive pulse oximeter sensor

INVSENSOR00012

Eligibility Criteria

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

You may qualify if:

• Subject is 18-50 years of age.
• Subject weighs a minimum of 110 lbs and no more than 250 lbs unless subject is over 6 feet tall.
• Hemoglobin value is greater than or equal to 11 g/dL.
• Baseline heart rate ≥ 45 bpm and ≤ 85 bpm.
• Carbon monoxide (CO) value ≤ 2.0% fractional carboxyhemoglobin (FCOHb)
• Subject has a physical status of American Society of Anesthesiology Class I; Healthy subjects without any systemic disease at all. American Society of Anesthesiology Class II; subjects with mild systemic disease (ASA I or II) as it applies to the systemic disease portion of the classification.
• Systolic Blood Pressure ≤ 140 mmHg and Diastolic Blood Pressure ≤ 90 mmHg.
• Subject is able to read and communicate in English and understands the study and risks involved.

You may not qualify if:

• Subject is pregnant.
• Subject smokes (smoking includes e-cigarette use).
• Subject has a BMI \> 35 and has been classified as morbidly obese or at an increased risk for participation by a medical professional.
• Subject has open wounds, inflamed tattoos or piercings, visible healing wounds.
• Subject experiences frequent or severe headaches and/or migraine headaches.
• Subject has known drug or alcohol abuse and/or use of recreational drugs.
• Subject has experienced a concussion or head injury with loss of consciousness within the last year.
• Subject has any chronic bleeding disorders (i.e. hemophilia).
• Subject has any history of a stroke, myocardial infarction, seizures or heart attack.
• Subject has any cancer or history of cancer (not including skin cancer).
• Subject has a chronic neurological disease (i.e. multiple sclerosis, Huntington's Disease).
• Subject has any cardiac dysrhythmia(s) (i.e. atrial fibrillation) and has not received clearance by their physician to participate.
• Subject has a known neurological and/or psychiatric disorder (i.e. schizophrenia, bipolar disorder) that interferes with the subject's level of consciousness.
• Subject has any medical condition which in the judgment of the investigator and/or medical staff, renders them ineligible for participation in this study (Discretion of investigator).
• Subject has Wolff-Parkinson-White Syndrome or Stokes-Adams Syndrome.

Sponsors & Collaborators

• Masimo Corporation: lead

Study Sites (1)

Masimo Corporation

Irvine, California, 92618, United States

Location

Results Point of Contact

• Title: Chelsea Frank
• Organization: Masimo

studies@masimo.com

(949) 297-7000

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: February 5, 2018
• First Posted: February 15, 2018
• Study Start: January 17, 2018
• Primary Completion: February 12, 2018
• Study Completion: February 12, 2018
• Last Updated: October 1, 2024
• Results First Posted: March 30, 2021

Record last verified: 2024-09

Locations

US (1)