Comparison of Rainbow INVSENSOR00001 and Control SpHb Disposable Sensor Performance During Hemodilution
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 82
- 试验地点
- 1
- 主要终点
- Comparison of INVSENSOR00001 and Control SpHb Sensor by ARMS Calculation
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
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.
干预措施: Control SpHb sensor (Device)
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.
干预措施: Hemodilution (Procedure)
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.
干预措施: INVSENSOR00001 (Device)
结局指标
主要结局
Comparison of INVSENSOR00001 and Control SpHb Sensor by ARMS Calculation
时间窗: 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.
次要结局
未报告次要终点