Desaturation Validation of INVSENSOR00031

NCT03783780 | Completed Results FDA Device

• 1 other identifier: TP-19564
• Study Type: interventional
• Target: 21
• 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 at various times during the study. The subject will then be returned to breathing room air.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Oxygen Saturation (SpO2) Accuracy of Sensor by Arms Calculation During Non-motion

  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 during non-motion.

  1-5 hours

Secondary Outcomes (1)

• Oxygen Saturation (SpO2) Accuracy of Sensor by Arms Calculation During Motion

  1-5 hours

Study Arms (1)

INVSENSOR00031

EXPERIMENTAL

All subjects who are enrolled into the test group and participate in data collection receive the noninvasive INVSENSOR00031 sensor during motion and non-motion.

Device: INVSENSOR00031

Interventions

INVSENSOR00031 DEVICE

Noninvasive pulse oximeter sensor

INVSENSOR00031

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 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 blood draw, or has a fear of blood draws.
• Subject has open wounds, inflamed tattoos or piercings, or any 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.
• 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 12 months.
• 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 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, Multiple Sclerosis, Huntington's Disease) that interferes with the subject's level of consciousness.
• Subject has Wolff-Parkinson-White Syndrome or Stokes-Adams Syndrome.
• Subject who 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: Tala Harake
• Organization: Masimo

studies@masimo.com

1-949-297-7100

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: December 19, 2018
• First Posted: December 21, 2018
• Study Start: December 11, 2018
• Primary Completion: December 18, 2018
• Study Completion: December 18, 2018
• Last Updated: December 17, 2019
• Results First Posted: July 2, 2019

Record last verified: 2019-11

Locations

US (1)