N/A
Completed N=354
Accuracy of Noninvasive Hemoglobin Sensor (Rainbow Reusable DCI)
Healthy
Source: ClinicalTrials.gov NCT03124758 ↗
Enrolled (actual)
354
Serious AEs
0.0%
Results posted
Jun 2017
Primary outcomePrimary: Accuracy of Sensor by Arms Calculation — 1.0 g/dL
Summary
In this study, the accuracy of a noninvasive hemoglobin sensor(s) will be assessed by comparison to hemoglobin measurements from a laboratory hematology analyzer. Blood samples are collected from healthy volunteers who are enrolled in either a blood draw procedure or a hemodilution procedure wherein blood is repeatedly sampled as the concentration of hemoglobin is reduced in a controlled manner by administering fluids intravenously.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Accuracy of Sensor by Arms Calculation |
1.0 | — |
Eligibility Criteria
A. Hemodilution Test Procedure
Inclusion Criteria
- Weight of more than 110 lbs and less than 220 lbs.
- 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 35 years
- Weight of less than 110 lbs or more than 220 lbs.
- Hemoglobin less than 12 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.
- 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
- Discretion of investigator
B. Blood Draw Test Procedure
Inclusion Criteria
-Subjects must understand and consent to be in the study.
Exclusion Criteria
- Subjects less than 18 years of age.
- Subjects who do not understand the study and the risks involved.
- Anyone deemed ineligible by test personnel.
Data sourced from ClinicalTrials.gov (NCT03124758). 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. Informational only — not medical advice.