Accuracy of Hemoglobin Measurement for Various Rainbow Pulse Oximeter Sensors
- Conditions
- Healthy
- Interventions
- Device: Pulse Oximeter sensor
- Registration Number
- NCT03124966
- Lead Sponsor
- Masimo Corporation
- 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(s) will be assessed by comparison to hemoglobin measurements from a laboratory analyzer.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 118
- Has physical status between ASA 1 or 2
- Able to communicate in English
- Pregnant or sexually active without birth control.
- Hemoglobin less than 11g/dL
- Known alcohol or drug abuse
- Skin abnormalities affecting the digits such as psoriasis, eczema, angioma, scar tissue, burn, fungal infection
- Nail polish
- Head injury with loss of consciousness within the last year
- Known neurological and psychiatric conditions.
- Known concurrent chronic usage of psychoactive or anti-convulsive drugs within the last 90 days, or use in the last 7 days (i.e. tricyclic antidepressants, MAO inhibitors, lithium, neuroleptics, anxiolytics or antipsychotics. Except SSRIs
- Subject has any medical condition which, in the judgement of the investigator, renders them inappropriate for participation in this study, such as Raynaud's syndrome
- Hypertension: Systolic BP >= 140 mmHg or Diastolic BP >= 90 mmHg
- Baseline heart rate <50 beats per minute
Study Site 2:
Inclusion Criteria:
- Male or female
- 18-35 years of age
- Physical status of ASA I or II
- Able to read and communicate in English
- Has signed written informed consent
- If female, non pregnant. If female subject is currently sexually active and not on birth control they must have a negative pregnancy test prior to study enrollment.
Exclusion Criteria
- Age less than 18 yrs and greater than 35 years
- Hemoglobin less than 12 g/dL
- ASA physical status of III, IV, or V
- Pregnant or sexually active without birth control
- Subject has known drug or alcohol abuse
- Subject has skin abnormalities affecting the digits such as psoriasis, eczema, angioma, scar tissue, burn, fungal infection, substantial skin breakdown, nail polish or acrylic nails.
- Subject has experienced a head injury with loss of consciousness within the last year
- Subject has known neurological and psychiatric disorder that interferes with the subjects level of consciousness
- Known or concurrent chronic usage of psychoactive or anticonvulsive drugs within the last 90 days, or any use in the last 7 day (i.e. tricyclic antidepressants, MAO inhibitors, lithium, neuroleptics, anxiolytics or antipsychotics, except SSRIs).
- Subject has any medical condition which in the judgment of the investigator, renders them inappropriate for participation in this study, such as Raynauds Syndrome.
- Hypertension: Systolic BP >140 mmHg or Diastolic BP > 90 mmHg.
- Baseline heart rate < 50 bpm.
- Inability to tolerate sitting still or minimal movement for up to 90 minutes
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Noninvasive Hemoglobin Sensor Pulse Oximeter sensor All subjects are enrolled into the test group and all will receive the pulse oximeter sensor.
- Primary Outcome Measures
Name Time Method Accuracy of Sensor by Arms Calculation 1-3 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
Masimo Clinical Lab
🇺🇸Irvine, California, United States
Loma Linda University Medical Center
🇺🇸Loma Linda, California, United States