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

Masimo

Status

Completed

Conditions

Healthy

Treatments

Device: Rainbow Resposable Adhesive Sensors

Study type

Interventional

Funder types

Industry

Identifiers

NCT03124771

TR23394-TP16171

Details and patient eligibility

About

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.

Enrollment

132 patients

Sex

All

Ages

18 to 40 years old

Volunteers

Accepts Healthy Volunteers

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