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

Not Applicable

Completed

Conditions: Healthy

Interventions: Device: INVSENSOR00001
Device: Control SpHb sensor
Procedure: Hemodilution

Registration Number: NCT03273166

Lead Sponsor: Masimo Corporation

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 82

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 & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
INVSENSOR00001 sensor	INVSENSOR00001	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.
INVSENSOR00001 sensor	Hemodilution	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.
INVSENSOR00001 sensor	Control SpHb 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.

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures