Status:
COMPLETED
Comparison of Rainbow INVSENSOR00001 and Control SpHb Disposable Sensor Performance During Hemodilution
Lead Sponsor:
Masimo Corporation
Conditions:
Healthy
Eligibility:
All Genders
18-50 years
Phase:
NA
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 hemoglo...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
August 29 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 18 2017
Estimated Enrollment :
82 Patients enrolled
Trial Details
Trial ID
NCT03273166
Start Date
August 29 2017
End Date
September 18 2017
Last Update
October 26 2020
Active Locations (1)
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1
Masimo Clinical Lab
Irvine, California, United States, 92618