Accuracy of Noninvasive Pulse Oximeter Measurement of Hemoglobin for Rainbow DCI Sensor
Completed · Not applicable
Conditions studied: Surgery, Healthy
In brief
In this study, the concentration of hemoglobin within the subject's blood is affected by fluid status changes. The fluid status is affected by fluid loss during surgery for hospitalized study subjects or controlled administration of fluids intravenously for healthy study volunteers. The accuracy of a noninvasive hemoglobin sensor(s) will be assessed by comparing with blood sample analysis.
Key facts
- Study ID
- NCT03124901
- Run by
- Masimo Corporation
- People needed
- 147
- Starts
- 2008-09-30
- Expected to finish
- 2008-10-27
- Last updated by the study team
- 2017-06-12
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 Reynods syndrome
- Hypertension: Systolic BP >= 140 mmHg or Diastolic BP >= 90 mmHg
- Baseline heart rate <50 beats per minute
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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