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N/A Completed N=88 Other

Comparison of Noninvasive Hemoglobin Disposable Sensors

Healthy
Source: ClinicalTrials.gov NCT03125031 ↗
Enrolled (actual)
88
Serious AEs
0.0%
Results posted
Jun 2017
Primary outcomePrimary: Accuracy of Noninvasive Sensors by Arms Calculation — 1.0; 1.0 g/dL

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 two noninvasive hemoglobin sensors will be assessed by comparison to hemoglobin measurements from a laboratory analyzer.

Outcome Measures

OutcomeResultp-value
PRIMARY
Accuracy of Noninvasive Sensors by Arms Calculation
1.0; 1.0 —

Eligibility Criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03125031). 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.

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