Healthy
Conditions
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.
Interventions
DEVICEINVSENSOR00001
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.
DEVICEControl 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.
PROCEDUREHemodilution
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.
Sponsors
Masimo Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Pre-assignment details
Fingers were not randomized to the two interventions. All participants received both interventions in the exact same manner.
Participants by arm
| Arm | Count |
|---|---|
| INVSENSOR00001 All subjects consented are enrolled into the test group and will receive the INVSENSOR00001 and the control sensor simultaneously on different fingers. | 51 |
| Total | 51 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawn prior to Completion | 31 |
Baseline characteristics
| Characteristic | INVSENSOR00001 |
|---|---|
| Age, Categorical <=18 years | 1 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 50 Participants |
| Race/Ethnicity, Customized Race/Ethnicity, Customized Asian or Pacific Islander | 3 Participants |
| Race/Ethnicity, Customized Race/Ethnicity, Customized Black or African American | 13 Participants |
| Race/Ethnicity, Customized Race/Ethnicity, Customized Caucasian | 17 Participants |
| Race/Ethnicity, Customized Race/Ethnicity, Customized Hispanic | 16 Participants |
| Race/Ethnicity, Customized Race/Ethnicity, Customized Native American | 2 Participants |
| Race/Ethnicity, Customized Race/Ethnicity, Customized Other | 0 Participants |
| Sex: Female, Male Female | 16 Participants |
| Sex: Female, Male Male | 35 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 51 |
| other Total, other adverse events | 2 / 51 |
| serious Total, serious adverse events | 0 / 51 |
Outcome results
Primary
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.
Time frame: 1-5 hours
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| INVSENSOR00001 | Comparison of INVSENSOR00001 and Control SpHb Sensor by ARMS Calculation | 0.9 g/dL |
| Control SpHb Sensor | Comparison of INVSENSOR00001 and Control SpHb Sensor by ARMS Calculation | 0.9 g/dL |