Comparison of Rainbow INVSENSOR00001 and Control SpHb Disposable Sensor Performance During Hemodilution

• Sponsor: Masimo Corporation (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03273166
• Collaborator: (none)
• Enrollment: 82
• Location: 1
• Arm: 1
• Actual Duration (Days): 20
• Patients Per Site Per Month: 124.8

Study Details

Study Description

Brief Summary

This study involves comparison of the performance of two SpHb sensors in subjects that undergo a hemodilution procedure. The sensors' performance will be assessed by comparison of the measured hemoglobin values against reference values obtained by a laboratory hematology analyzer. Blood samples will be collected from healthy volunteers who undergo a hemodilution procedure wherein blood is repeatedly sampled as the concentration of hemoglobin is reduced by administering intravenous fluids to the volunteer in a controlled manner.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Device: INVSENSOR00001; Device: Control SpHb sensor; Procedure: Hemodilution	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 82 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Comparison of Rainbow INVSENSOR00001 and Control SpHb Disposable Sensor Performance During Hemodilution
• Actual Study Start Date: Aug 29, 2017
• Actual Primary Completion Date: Sep 18, 2017
• Actual Study Completion Date: Sep 18, 2017

Arms and Interventions

Arm

Intervention/Treatment

Experimental: INVSENSOR00001 sensor This is a nonrandomized single arm study wherein all subjects are enrolled into the experimental arm and receive both the INVSENSOR00001 sensor and the control sensor simultaneously on different fingers.

Device: INVSENSOR00001; This is a non-randomized single arm study wherein all subjects are enrolled into the experimental arm and receive both the INVSENSOR00001 sensor and the control sensor simultaneously on different fingers.; Device: Control SpHb sensor; This is a non-randomized single arm study wherein all subjects are enrolled into the experimental arm and receive both the INVSENSOR00001 sensor and the control sensor simultaneously on different fingers.; Procedure: Hemodilution; This is a non-randomized single arm study wherein all subjects are enrolled into the experimental arm and receive both the INVSENSOR00001 sensor and the control sensor simultaneously on different fingers while undergoing a hemodilution procedure.

Outcome Measures

Primary Outcome Measures

1. Comparison of INVSENSOR00001 and Control SpHb Sensor by ARMS Calculation [1-5 hours]

   Performance of the sensors will be determined by comparing the noninvasive hemoglobin measurement (SpHb) of the pulse oximeter sensors to the hemoglobin value obtained from a reference blood sample and calculating the accuracy root mean square(ARMS) value.

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Competent adults between the ages of 18 and 50 years of age

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

• BMI ≤ 35 unless the physician determines that a higher BMI is not due to morbid obesity, to safeguard subject safety during hemodilution

• Must have a hemoglobin value ≥ 11 g/dL at time of screening, to safeguard subject safety during hemodilution

• Baseline heart rate between 45 bpm and 85 bpm

• CO value less than 2.0% FCOHb

• 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) The ASA definition strictly applies to the systemic disease portion of the classification

• Systolic BP less than or equal to 140 mmHg and Diastolic BP less than or equal to 90 mmHg

• Able to read and communicate in English

Exclusion Criteria:

• Pregnancy or positive hCG test

• Smokers (including e-cigarette users)

• Subject has known drug or alcohol abuse. Subjects who uses recreational drugs

• Subject has experienced a concussion or head injury with loss of consciousness within the last year

• Any chronic bleeding disorders (i.e. hemophilia)

• Any history of a stroke, myocardial infarction, or seizures

• Any cancer or history of cancer (not including skin cancer)

• Chronic neurological diseases (i.e. multiple sclerosis, Huntington's Disease)

• Any cardiac dysrhythmias (i.e. atrial fibrillation)(without physicians clearance)

• Subject has known neurological and/or psychiatric disorder (i.e. schizophrenia, bipolar disorder) that interferes with the subject's level of consciousness

• Subject has Wolff-Parkinson-White Syndrome or Stokes-Adams Syndrome

• Subjects who have/are currently taking anticoagulant medication

• Subjects who have taken opioid pain medication within 24 hours of start of study

• Subjects who do not understand the study and the risks

• Subjects having either signs or history of peripheral ischemia

• 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 ENT surgery, joint replacement or gynecological surgeries, heart surgery or thoracic surgery

• Subjects that have symptoms of congestion, head colds, flu, or other illnesses

• Subjects with claustrophobia, or generalized anxiety disorder

• Subjects who have been in severe car accident(s) or a similar type of accident(s) requiring hospitalization within the last 12 months

• Subjects with chronic unresolved asthma, lung disease and respiratory disease

• Subjects with allergies to lidocaine, latex, adhesives, or plastic

• Subjects with heart conditions, insulin-dependent diabetes or uncontrolled hypertension

• Subjects who have given vaginal delivery, had a pregnancy terminated, a miscarriage with hospitalization or had a c-section within the last 6 months

• Subjects who intend on participating 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 following a study involving an arterial blood draw and/or arterial line placement

• 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)

Contacts and Locations

Locations

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

Sponsors and Collaborators

• Masimo Corporation

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - May 8, 2018

More Information

Publications

None provided.

• Responsible Party: Masimo Corporation
• ClinicalTrials.gov Identifier: NCT03273166
• Other Study ID Numbers: TP-18788
• First Posted: Sep 6, 2017
• Last Update Posted: Oct 26, 2020
• Last Verified: Oct 1, 2020

• 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.: Yes

Study Results

Participant Flow

Pre-assignment Detail	Fingers were not randomized to the two interventions. All participants received both interventions in the exact same manner.

Arm/Group Title	INVSENSOR00001
Arm/Group Description	All subjects consented are enrolled into the test group and will receive the INVSENSOR00001 and the control sensor simultaneously on different fingers.
Period Title: Overall Study
STARTED	82
COMPLETED	51
NOT COMPLETED	31

Baseline Characteristics

Arm/Group Title	INVSENSOR00001
Arm/Group Description	All subjects consented are enrolled into the test group and will receive the INVSENSOR00001 and the control sensor simultaneously on different fingers.
Overall Participants	51
Age (Count of Participants)
<=18 years	1 2%
Between 18 and 65 years	50 98%
>=65 years	0 0%
Sex: Female, Male (Count of Participants)
Female	16 31.4%
Male	35 68.6%
Race/Ethnicity, Customized (Count of Participants)
Caucasian	17 33.3%
Hispanic	16 31.4%
Asian or Pacific Islander	3 5.9%
Native American	2 3.9%
Black or African American	13 25.5%
Other	0 0%

Outcome Measures

1. Primary Outcome

Title	Comparison of INVSENSOR00001 and Control SpHb Sensor by ARMS Calculation
Description	Performance of the sensors will be determined by comparing the noninvasive hemoglobin measurement (SpHb) of the pulse oximeter sensors to the hemoglobin value obtained from a reference blood sample and calculating the accuracy root mean square(ARMS) value.
Time Frame	1-5 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	INVSENSOR00001	Control SpHb Sensor
Arm/Group Description	All subjects consented are enrolled into the test group and will receive the INVSENSOR00001 and the control sensor simultaneously on different fingers.	All subjects consented are enrolled into the test group and will receive the INVSENSOR00001 and the control sensor simultaneously on different fingers.
Measure Participants	51	51
Number [g/dL]	0.9	0.9

Adverse Events

Time Frame	1 to 5 hours
Adverse Event Reporting Description	Adverse Events were not collected with respect to the interventions, only on participants as a whole.
Arm/Group Title	INVSENSOR00001
Arm/Group Description	All subjects consented are enrolled into the test group and will receive the INVSENSOR00001 and the control sensor simultaneously on different fingers.
All Cause Mortality
	INVSENSOR00001
	Affected / at Risk (%)	# Events
Total	0/51 (0%)
Serious Adverse Events
	INVSENSOR00001
	Affected / at Risk (%)	# Events
Total	0/51 (0%)
Other (Not Including Serious) Adverse Events
	INVSENSOR00001
	Affected / at Risk (%)	# Events
Total	2/51 (3.9%)
Injury, poisoning and procedural complications
Dizziness	1/51 (2%)
Irregular EKG readings	1/51 (2%)

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.