Accuracy of Hemoglobin Measurement for Various Rainbow Pulse Oximeter 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 a noninvasive hemoglobin sensor(s) will be assessed by comparison to hemoglobin measurements from a laboratory analyzer.
Key facts
- Study ID
- NCT03124966
- Run by
- Masimo Corporation
- People needed
- 118
- Starts
- 2009-12-09
- Expected to finish
- 2009-12-31
- Last updated by the study team
- 2017-07-27
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Has physical status between ASA 1 or 2
- Able to communicate in English
You may not qualify if…
- 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
Where it is running
- Masimo Clinical Lab — Irvine, California, United States
- Loma Linda University Medical Center — Loma Linda, California, United States
Full record on ClinicalTrials.gov
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