Accuracy of Oxygen Saturation (SpO2) Noninvasive Pulse Oximeter Sensor (RD Disposable) Under Motion Conditions

• Sponsor: Masimo Corporation (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03124784
• Collaborator: (none)
• Enrollment: 27
• Location: 1
• Arm: 1
• Actual Duration (Days): 17
• Patients Per Site Per Month: 48.3

Study Details

Study Description

Brief Summary

In this study, the level of oxygen within the blood will be reduced in a controlled manner by reducing the concentration of oxygen the study volunteer breathes. The accuracy of a noninvasive pulse oximeter sensor under motion conditions will be assessed by comparison to the oxygen saturation measurements from a laboratory blood gas analyzer.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Device: RD Disposable Sensors	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 27 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Actual Study Start Date: Jan 3, 2017
• Actual Primary Completion Date: Jan 20, 2017
• Actual Study Completion Date: Jan 20, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: RD Disposable Sensors All subjects are enrolled into the test group and all subjects received the RD Disposable Sensors	Device: RD Disposable Sensors; Noninvasive pulse oximeter sensor

Outcome Measures

Primary Outcome Measures

1. SpO2 ARMS of Sensor Under Motion Conditions [1-5 hours]

   Accuracy will be determined by comparing the noninvasive blood oxygen saturation measurement of the pulse oximeter to that obtained from a blood sample and calculating the arithmetic root mean square error (Arms) value. In order to obtain the Arms value, the blood oxygen saturation measurement is subtracted from the pulse oximeter oxygen saturation measurement for a number of samples, the average of this difference is computed as the bias. The standard deviation of the differences is computed as the precision. The square root of the sum of the squares of bias and precision is computed as the Arms Error value.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Competent non-smoking adults

• Must weigh a minimum of 110 pounds and no more than 250 pounds unless subject is over 6 feet tall.

• Subjects must understand and consent to be in the study.

• American Society of Anesthesiology Class 1 (Healthy subjects without any systemic disease at all).

• Subjects with hemoglobin greater than or equal to 11 g/dL.

Exclusion Criteria:

• Subjects with polished, gel or acrylic nails.

• Subjects with damaged and/or finger nail deformities.

• Subjects who have had caffeine consumption the day of the study.

• Subjects who have taken pain medication 24 hours before the study.

• Subjects who have any systemic disease at all.

• Subjects who do not understand the study and the risks.

• Subjects who smoke.

• Subjects who use recreational drugs.

• Subjects who are pregnant or nursing.

• Subjects having either signs or history of peripheral ischemia.

• Subjects with open wounds, lacerations, inflamed tattoos or piercings, visible healing wounds.

• Subjects with psychiatric conditions or are on psychiatric medications.

• Subjects who have 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 ears, nose throat (ENT) surgery, joint replacement or gynecological surgeries.

• Subjects who have had minor surgery or conditions in the past two months including but not limited to minor foot surgery (bunion), arthroscopic procedure, blood donation, plasma donation, skin biopsy/ procedures, root canal, fractures, eye surgery, and other minor procedures.

• Subjects that have been on antibiotics had congestion, head colds, flu, ear infection, chest congestion will have a 2 week waiting period from the time of finishing medications or must have no more symptoms.

• Subjects with claustrophobia, or anxiety.

• Subjects who have been in severe car accidents or a similar type of accidents will have a 12 month waiting period, from the time of the accident.

• Subjects who have had a concussion will have a 12 month waiting period, from the time of the concussion.

• Subjects with chronic unresolved asthma, lung disease and respiratory disease. Allergies to lidocaine, latex, adhesives, or plastic.

• Subjects with finger deformities or injuries (specific finger will not be used).

• Subjects with heart conditions, diabetes or hypertension.

• Subjects with resting heart rates greater than 85 beats per minute (BPM) or below 45 BPM

• Subjects who have given birth naturally will have 6 month waiting period. Subjects who had a pregnancy terminated, a miscarriage or had a c-section will have a 12 month waiting period.

• Others deemed ineligible by the clinical 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 - Sep 22, 2015

More Information

Publications

None provided.

• Responsible Party: Masimo Corporation
• ClinicalTrials.gov Identifier: NCT03124784
• Other Study ID Numbers: TR33143-000190A
• First Posted: Apr 24, 2017
• Last Update Posted: Mar 23, 2018
• Last Verified: Feb 1, 2018

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No

Study Results

Participant Flow

Arm/Group Title	RD Disposable Sensors
Arm/Group Description	All subjects are enrolled into the test group and all subjects received the RD Disposable Sensors
Period Title: Overall Study
STARTED	27
COMPLETED	25
NOT COMPLETED	2

Baseline Characteristics

Arm/Group Title	RD Disposable Sensors
Arm/Group Description	All subjects are enrolled into the test group and all subjects received the RD Disposable Sensors RD Disposable Sensors: Noninvasive pulse oximeter sensor
Overall Participants	25
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	25 100%
>=65 years	0 0%
Sex: Female, Male (Count of Participants)
Female	13 52%
Male	12 48%
Race/Ethnicity, Customized (Count of Participants)
African American	7 28%
Asian or Pacific Islander	4 16%
Caucasian	7 28%
Hispanic	7 28%
Region of Enrollment (Count of Participants)
United States	25 100%

Outcome Measures

1. Primary Outcome

Title	SpO2 ARMS of Sensor Under Motion Conditions
Description	Accuracy will be determined by comparing the noninvasive blood oxygen saturation measurement of the pulse oximeter to that obtained from a blood sample and calculating the arithmetic root mean square error (Arms) value. In order to obtain the Arms value, the blood oxygen saturation measurement is subtracted from the pulse oximeter oxygen saturation measurement for a number of samples, the average of this difference is computed as the bias. The standard deviation of the differences is computed as the precision. The square root of the sum of the squares of bias and precision is computed as the Arms Error value.
Time Frame	1-5 hours

Outcome Measure Data

Analysis Population Description

2 subjects were excluded from data analysis: one due to adverse event and the other due to equipment malfunction.

Arm/Group Title	RD Disposable Sensors
Arm/Group Description	All subjects are enrolled into the test group and all subjects received the RD Disposable Sensors
Measure Participants	25
Number [% of oxygen saturated hemoglobin]	1.31

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	RD Disposable Sensors
	Comments	Accuracy Root Mean Square (ARMS)
	Type of Statistical Test	Equivalence
	Comments	ARMS<= 3 %SpO2 Error per International Organization For Standardization (ISO) -80601-2-61 Pilot study Monte Carlo simulation provided 80% Power with 25 subjects for an expected ARMS< 3 % SpO2.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	ARMS
	Estimated Value	0
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments
Other Statistical Analysis		Per ISO-80601-2-61, the Root Mean Square difference (SpO2-SaO2) is the measure of merit for desaturation studies.

Adverse Events

Time Frame	Adverse event data was collected over the course of the study (within 1 month).
Arm/Group Title	RD Disposable Sensors
Arm/Group Description	All subjects are enrolled into the test group and all subjects received the RD Disposable Sensors
All Cause Mortality
	RD Disposable Sensors
	Affected / at Risk (%)	# Events
Total	0/27 (0%)
Serious Adverse Events
	RD Disposable Sensors
	Affected / at Risk (%)	# Events
Total	0/27 (0%)
Other (Not Including Serious) Adverse Events
	RD Disposable Sensors
	Affected / at Risk (%)	# Events
Total	2/27 (7.4%)
General disorders
Irregular heart rate	1/27 (3.7%)	1
Injury, poisoning and procedural complications
Sensitivity at site of arterial line placement	1/27 (3.7%)	1

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.