Comparison of Noninvasive Hemoglobin Disposable Sensors
Completed · Not applicable
Conditions studied: Healthy
In brief
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 two noninvasive hemoglobin sensors will be assessed by comparison to hemoglobin measurements from a laboratory analyzer.
Key facts
- Study ID
- NCT03125031
- Run by
- Masimo Corporation
- People needed
- 44
- Starts
- 2014-07-10
- Expected to finish
- 2014-07-25
- Last updated by the study team
- 2017-07-27
Who can join
Age: 18 and older, up to 40. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Male or female
- 18-40 years of age
- Weight of at least 110 lbs and less than 250 lbs for subjects under 6 feet tall.
- Physical status of ASA I of II
- Able to read and communicate in English
- Has signed written informed consent
- Female, non pregnant.
You may not qualify if…
- Age less than 18 yrs and greater than 40 years
- If the Warming and cooling subjects have open cuts of skin abrasions on their extremities they will be excluded because alcohol spray may be painful.
- Weight of less than 110 lbs or more than 250 lbs if the subject is less than 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
Where it is running
- Masimo Clinical Lab — Irvine, California, United States
Full record on ClinicalTrials.gov
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