N/A
N=132
Accuracy of Noninvasive Hemoglobin Pulse Oximeter (Rainbow Resposable Adhesive Sensors)
Healthy
Bottom Line
View on ClinicalTrials.gov: NCT03124771 ↗Enrolled (actual)
132
Serious AEs
0.0%
Results posted
Jun 2017
Primary outcome: Primary: Accuracy of Sensor by Arms Calculation — 1.0 g/dL
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Rainbow Resposable Adhesive Sensors (Device)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Masimo Corporation
- Primary completion
- Apr 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Accuracy of Sensor by Arms Calculation |
1.0 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Male or female
- 18-40 years of age
- Weight of at least 110 lbs and less than 250 lbs or a BMI under 36 for subjects taller than 6 feet.
- Physical status of ASA I of II
- Able to read and communicate in English
- Has signed written informed consent
- Female, non pregnant. Female subjects will be provided with a pregnancy test free of charge.
Exclusion Criteria
- Age less than 18 yrs and greater than 40 years
- Weight of less than 110 lbs or more than 250 lbs. or a BMI of 36 or greater for people over 6 feet tall.
- Hemoglobin less than 11 g/dL
- ASA physical status of III. IV, V.
- Pregnant
- 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, Lithum, 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 Reynauds Syndrome.
- Systolic BP >140 mmHg or Diastolic BP > 100 mmHg.
- Baseline heart rate < 50 bpm.
- Inability to tolerate sitting still or minimal movement for up to 90 minutes
- Discretion of investigator
Data sourced from ClinicalTrials.gov (NCT03124771). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.