Hemodilution Validation of INVSENSOR00026
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Healthy
- Sponsor
- Masimo Corporation
- Enrollment
- 173
- Locations
- 1
- Primary Endpoint
- Accuracy of Noninvasive Hemoglobin Sensor by Arms Calculation
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
In this study, the concentration of hemoglobin within the subject's blood will be reduced in a controlled manner by administering fluids intravenously. The accuracy of a noninvasive hemoglobin sensor will be assessed by comparison to hemoglobin measurements from a laboratory analyzer.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subject weighs a minimum of 110 lbs and no more than 250 lbs unless subject is over 6 feet tall.
- •Hemoglobin value is greater than or equal to 11 g/dL at time of screening
- •Baseline heart rate ≥ 45 bpm and ≤ 85 bpm.
- •CO value ≤ 2.0% FCOHb
- •Subject has a 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) as it applies to the systemic disease portion of the classification.
- •Systolic Blood Pressure ≤ 140 mmHg and Diastolic Blood Pressure ≤ 90 mmHg.
- •Subject is able to read and communicate in English and understands the study and risks involved.
Exclusion Criteria
- •Subject is pregnant
- •Subject smokes (including e-cigarette use)
- •Subject has a BMI \> 35 and has been classified as morbidly obese or at an increased risk for participation by a medical professional.
- •Subject has a history of fainting (vasovagal), blacking out or losing consciousness during or after a blood draw.
- •Subject has open wounds, inflamed tattoos or piercings, or any visible healing wounds.
- •Subject has known drug or alcohol abuse or uses recreational drugs.
- •Subject has experienced a head injury with loss of consciousness within the last year.
- •Subject has taken anticoagulant medication within the last 30 days.
- •Subject has any chronic bleeding disorders (i.e. hemophilia).
- •Subject has any history of a stroke, myocardial infarction, heart attack, or seizures.
Outcomes
Primary Outcomes
Accuracy of Noninvasive Hemoglobin Sensor by Arms Calculation
Time Frame: 1-5 hours
Accuracy will be determined by comparing the noninvasive hemoglobin measurement of the pulse oximeter to the hemoglobin value obtained from a blood sample and calculating the arithmetic root mean square (Arms) error value. In order to obtain the Arms value, the blood sample hemoglobin value is subtracted from the pulse oximeter hemoglobin value for a number of samples, the average of this difference is computed as the bias. The standard deviation of the differences is computed as the precision. The square root of the sum of the squares of bias and precision is computed as the Arms Error value.