- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03396835
Desaturation Validation of INVSENSOR00009
August 9, 2019 updated by: Masimo Corporation
This study is designed to measure the trending accuracy of a noninvasive measurement of cerebral oxygen saturation.
One Large sensor (adult sensor) and one INVSENSOR00009 will be placed on the subject's forehead.
The values obtained by the INVSENSOR00009 will be compared to the values collected with the adult sensor.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%.
The subject will then be returned to inhaling room air.
Study Overview
Study Type
Interventional
Enrollment (Actual)
16
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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Irvine, California, United States, 92618
- Masimo Clinical Lab
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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% FCOHb (Fractional saturation of hemoglobin with Carbon monoxide)
- Subject has a physical status of American Society of Anesthesiology (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.
Exclusion Criteria:
- 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.
- Subject who has taken anticoagulant medication within the last 30 days.
- Subject has taken opioid pain medication within 24 hours of start of study.
- Subject has either signs or history of peripheral ischemia.
- Subject has had invasive surgery within the past year- including but not limited to major dental surgery, gallbladder, heart, appendix, major fracture repairs (involving plates/ screws), jaw surgery, urinary tract surgery, plastic surgery, major ear nose and throat (ENT) surgery, joint replacement or gynecological surgeries, heart surgery or thoracic surgery.
- Subject has donated blood within the past 30 days.
- Subject has symptoms of congestion, head colds, flu or other illnesses.
- Subject experiences claustrophobia or has generalized anxiety disorder.
- Subject has been in severe car accident(s) or a similar type of accident(s) requiring hospitalization within the last 12 months.
- Subject has chronic unresolved asthma, lung disease or respiratory disease.
- Subject is allergic to lidocaine, latex, adhesives, or plastic.
- Subject has heart conditions, insulin-dependent diabetes or uncontrolled hypertension.
- Subject has given vaginal delivery, had a pregnancy terminated, a miscarriage with hospitalization, or had a C-section within the last 6 months.
- Discretion of investigator/study staff.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: INVSENSOR00009 Sensor
All subjects who are enrolled into the test group and participate in data collection receive both the INVSENSOR00009 and the control sensor simultaneously on the forehead.
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All subjects who are enrolled into the test group and participate in data collection receive both the INVSENSOR00009 and the control sensor simultaneously on the forehead.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Trending Regional Oxygen Saturation Accuracy of the INVSENSOR00009 Relative to the Control Sensor by Arms Calculation
Time Frame: 1-5 hours
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Trending ARMs accuracy is defined as root mean squared relative error of all data points of all subjects.
Accuracy of the sensors will be determined by comparing regional oxygen saturation (rSO2) readings from INVSENSOR00009 and control sensor and calculating the Arithmetic root mean square (ARMS) value.
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1-5 hours
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 18, 2017
Primary Completion (Actual)
January 16, 2018
Study Completion (Actual)
January 16, 2018
Study Registration Dates
First Submitted
January 5, 2018
First Submitted That Met QC Criteria
January 5, 2018
First Posted (Actual)
January 11, 2018
Study Record Updates
Last Update Posted (Actual)
August 28, 2019
Last Update Submitted That Met QC Criteria
August 9, 2019
Last Verified
August 1, 2019
More Information
Terms related to this study
Other Study ID Numbers
- TP-19029
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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