Desaturation Validation of INVSENSOR00028

NCT03704636 | Completed Results FDA Device

• 1 other identifier: TP-19457
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

This study is designed to measure the trending accuracy of a noninvasive regional oximetry measurement of somatic oxygen saturation. Two large sensors (adult sensors) will be placed on the subject's forehead. Two investigational sensors (INVSENSOR00028) will be placed on the forearm of the volunteer. The values obtained by the INVSENSOR00028 will be compared to the reference value calculated from the arterial and venous blood measurements. Data 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 saturation is approximately 70%, while blood samples are drawn at prespecified reference points. The subject will then be returned to inhaling room air.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Oxygen Saturation (rSO2) Accuracy of Sensor

  The Trending accuracy of the INVSENSOR00028 will be evaluated relative to the reference value calculated from the arterial and venous blood measurements.

  1-5 hours

Study Arms (1)

Test Subject

EXPERIMENTAL

All subjects who are enrolled into the test group and participate in data collection receive the noninvasive INVSENSOR00028 sensor.

Device: INVSENSOR00028

Interventions

INVSENSOR00028 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:

• 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.
• CO value ≤ 2.0% FCOHb
• Subject has a physical status of ASA I or II (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) 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 a history of fainting (vasovagal), blacking out or losing consciousness during or after a blood draw.
• 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).

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 Corporation

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: October 10, 2018
• First Posted: October 15, 2018
• Study Start: September 25, 2018
• Primary Completion: October 24, 2018
• Study Completion: October 24, 2018
• Last Updated: July 15, 2021
• Results First Posted: July 15, 2021

Record last verified: 2021-06

Locations

US (1)