Desaturation Validation of INVSENSOR00028

• Sponsor: Masimo Corporation (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03704636
• Collaborator: (none)
• Enrollment: 46
• Location: 1
• Arm: 1
• Actual Duration (Days): 29
• Patients Per Site Per Month: 48.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Device: INVSENSOR00028	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 46 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Desaturation Validation of INVSENSOR00028
• Actual Study Start Date: Sep 25, 2018
• Actual Primary Completion Date: Oct 24, 2018
• Actual Study Completion Date: Oct 24, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Test Subject All subjects who are enrolled into the test group and participate in data collection receive the noninvasive INVSENSOR00028 sensor.	Device: INVSENSOR00028; Noninvasive pulse oximeter sensor

Outcome Measures

Primary Outcome Measures

1. Oxygen Saturation (rSO2) Accuracy of Sensor [1-5 hours]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 50 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• 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.

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 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).

• 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 any type of infectious disease (i.e. Hepatitis, HIV, Tuberculosis, Flu, Malaria, Measles, etc.).

• Subject is taking medications known to treat any type of infectious disease.

• 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 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.

• Subject intends to participate in any heavy lifting, repetitive movement of their wrist (including riding a motorcycle) or exercise (working out, riding a bike, riding a skate board etc.), or any activity that will put additional stress on the wrist within 24 hours of the study.

• Discretion of investigator/study staff.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Masimo Corporation	Irvine	California	United States	92618

Sponsors and Collaborators

• Masimo Corporation

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Feb 26, 2019

More Information

Publications

None provided.

• Responsible Party: Masimo Corporation
• ClinicalTrials.gov Identifier: NCT03704636
• Other Study ID Numbers: TP-19457
• First Posted: Oct 15, 2018
• Last Update Posted: Jul 15, 2021
• Last Verified: Jun 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes

Study Results

Participant Flow

Pre-assignment Detail	Of the 46 enrolled participants, 23 met inclusion criteria and proceeded to the study. The remainder of the enrolled participants include screen failures and subjects that did not proceed due to time constraints.

Arm/Group Title	Test Subject
Arm/Group Description	All subjects who are enrolled into the test group and participate in data collection receive the noninvasive INVSENSOR00028 sensor. INVSENSOR00028: Noninvasive pulse oximeter sensor
Period Title: Overall Study
STARTED	23
COMPLETED	20
NOT COMPLETED	3

Baseline Characteristics

Arm/Group Title	Test Subject
Arm/Group Description	All subjects who are enrolled into the test group and participate in data collection receive the noninvasive INVSENSOR00028 sensor. INVSENSOR00028: Noninvasive pulse oximeter sensor
Overall Participants	20
Age, Customized (Count of Participants)
< 18 years old	0 0%
18 to 50 years old	20 100%
> 50 years old	0 0%
Sex: Female, Male (Count of Participants)
Female	8 40%
Male	12 60%
Race/Ethnicity, Customized (Count of Participants)
Asian or Pacific Islander	2 10%
Caucasian	8 40%
Black or African American	6 30%
Hispanic	4 20%

Outcome Measures

1. Primary Outcome

Title	Oxygen Saturation (rSO2) Accuracy of Sensor
Description	The Trending accuracy of the INVSENSOR00028 will be evaluated relative to the reference value calculated from the arterial and venous blood measurements.
Time Frame	1-5 hours

Outcome Measure Data

Analysis Population Description

There is no apparent trend in either the Brachial or Flexor RSO2 data with respect to the control. Since there is no measurable trend, a numerical value for Trending Accuracy (as defined in the protocol) cannot be accurately determined.

Arm/Group Title	Test Subject
Arm/Group Description	All subjects who are enrolled into the test group and participate in data collection receive the noninvasive INVSENSOR00028 sensor. INVSENSOR00028: Noninvasive pulse oximeter sensor
Measure Participants	0

Adverse Events

Time Frame	1 to 5 hours
Arm/Group Title	Test Subject
Arm/Group Description	All subjects who are enrolled into the test group and participate in data collection receive the noninvasive INVSENSOR00028 sensor. INVSENSOR00028: Noninvasive pulse oximeter sensor
All Cause Mortality
	Test Subject
	Affected / at Risk (%)	# Events
Total	0/20 (0%)
Serious Adverse Events
	Test Subject
	Affected / at Risk (%)	# Events
Total	0/20 (0%)
Other (Not Including Serious) Adverse Events
	Test Subject
	Affected / at Risk (%)	# Events
Total	3/20 (15%)
Injury, poisoning and procedural complications
Hematoma	1/20 (5%)
Sensitivity at arterial line site	1/20 (5%)
Lightheadedness	1/20 (5%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.