Desaturation Validation of INVSENSOR00036

NCT04002960 | Completed Results FDA Device

• 1 other identifier: TP-19901
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

This study is designed to evaluate the trending accuracy of a noninvasive regional oximetry measurement of somatic oxygen saturation. One investigational sensor (INVSENSOR00036) will be placed on the somatic site of the volunteer. The values obtained by the test sensor will be compared to the reference value obtained from an FDA-cleared sensor placed on the somatic site on the contralateral side.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Trending Accuracy of INVSENSOR00036

  This study will evaluate the trending accuracy of the INVSENSOR00036 relative to the reference value obtained from the comparative FDA-cleared device.

  1-5 hours

Study Arms (1)

INVSENSOR00036

EXPERIMENTAL

All subjects who are enrolled into the test group and participate in data collection receive the noninvasive INVSENSOR00036 sensor

Device: INVSENSOR00036

Interventions

INVSENSOR00036 DEVICE

Noninvasive regional oximeter

INVSENSOR00036

Eligibility Criteria

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

You may qualify if:

• Subject is between 18 and 50 years of age.
• Subject weighs a minimum of 110 lbs and no more than 250 lbs unless subject is over 6 feet tall.
• Must have a hemoglobin value greater than or equal to 11 g/dL.
• Baseline heart rate ≥ 45 bpm and ≤ 85 bpm.
• Blood Pressure (Systolic BP \< 140 mmHg and Diastolic BP \< 90 mmHg).
• Carbon monoxide (CO) value less than or equal to 2.0% fractional carboxyhemoglobin (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.
• 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 (including 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, or has a fear of blood draws.
• Subject has open wounds, inflamed tattoos or piercings and/or visible healing wounds that a medical professional renders them at an increased risk for participation.\*
• Subject experiences frequent or severe headaches and/or migraine headaches, migraine auras, altitude sickness, and/or headaches accompanied by visual changes or sensitivity to light or sound.
• Subject has known drug or alcohol abuse and/or uses 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 known neurological and/or psychiatric disorder (i.e. schizophrenia, bipolar disorder, Multiple Sclerosis, Huntington's disease) that interferes with the subjects' level of consciousness.
• Subject has any cardiac dysrhythmia(s) (i.e. atrial fibrillation) and has not received clearance by their physician to participate.
• Subject has Wolff-Parkinson-White Syndrome or Stokes-Adams Syndrome.
• Subject has taken anticoagulant medication within the last 30 days (excluding nonsteroidal anti-inflammatory drugs (NSAIDS)).

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: June 27, 2019
• First Posted: July 1, 2019
• Study Start: June 14, 2019
• Primary Completion: July 5, 2019
• Study Completion: July 5, 2019
• Last Updated: October 20, 2020
• Results First Posted: October 20, 2020

Record last verified: 2020-09

Locations

US (1)