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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Device: INVSENSOR00001; Device: Control SpHb sensor; Procedure: Hemodilution

• Study Type: Interventional
• Enrollment (Actual): 82
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Irvine, California, United States, 92618
      • Masimo Clinical Lab

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of INVSENSOR00001 and Control SpHb Sensor by ARMS Calculation	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.	1-5 hours

Collaborators and Investigators

• Sponsor: Masimo Corporation

Study record dates

Study Major Dates

• Study Start (Actual): August 29, 2017
• Primary Completion (Actual): September 18, 2017
• Study Completion (Actual): September 18, 2017

Study Registration Dates

• First Submitted: September 1, 2017
• First Submitted That Met QC Criteria: September 1, 2017
• First Posted (Actual): September 6, 2017

Study Record Updates

• Last Update Posted (Actual): October 26, 2020
• Last Update Submitted That Met QC Criteria: October 22, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: TP-18788

Drug and device information, study documents

• 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