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N/A N=132 Other

Accuracy of Noninvasive Hemoglobin Pulse Oximeter (Rainbow Resposable Adhesive Sensors)

Healthy

Enrolled (actual)
132
Serious AEs
0.0%
Results posted
Jun 2017
Primary outcome: Primary: Accuracy of Sensor by Arms Calculation — 1.0 g/dL

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Rainbow Resposable Adhesive Sensors (Device)
Age
Adult · 18+ yrs
Sex
All
Sponsor
Masimo Corporation
Primary completion
Apr 2012

Outcome Measures

OutcomeResultp-value
PRIMARY
Accuracy of Sensor by Arms Calculation
1.0

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 a noninvasive hemoglobin sensor(s) will be assessed by comparison to hemoglobin measurements from a laboratory analyzer.

Eligibility Criteria

Inclusion Criteria

  • Male or female
  • 18-40 years of age
  • Weight of at least 110 lbs and less than 250 lbs or a BMI under 36 for subjects taller than 6 feet.
  • 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 40 years
  • Weight of less than 110 lbs or more than 250 lbs. or a BMI of 36 or greater for people over 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 (NCT03124771). 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.

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