Clinical trial NCT03273166: Comparison of Rainbow INVSENSOR00001 and Control SpHb Disposable Sensor Performance During Hemodilution
Official title: Comparison of Rainbow INVSENSOR00001 and Control SpHb Disposable Sensor Performance During Hemodilution
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: Masimo Corporation
Sponsor class: INDUSTRY
First posted: 2017-09-06
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Comparison of INVSENSOR00001 and Control SpHb Sensor by ARMS Calculation
timeFrame: 1-5 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Irvine
country: United States
facility: Masimo Clinical Lab
state: California
Study officials:
References: