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

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Device: Rainbow Resposable Adhesive Sensors

• Registration Number: NCT03124771
• Lead Sponsor: Masimo Corporation

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12-27
• Primary Completion: 2012-04-03
• Study Completion: 2012-04-03
• Study First Submitted: 2017-04-14
• Study First Submitted QC: 2017-04-20
• Study First Posted: 2017-04-24
• Results First Submitted: 2017-05-08
• Results First Submitted QC: 2017-05-08
• Status Verified: 2017-06
• Results First Posted: 2017-06-06
• Last Update Submitted: 2017-06-28
• Last Update Posted: 2017-07-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 132

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Rainbow Resposable Adhesive Sensors	Rainbow Resposable Adhesive Sensors	All subjects are enrolled into the test group and all subjects received the Rainbow Resposable Adhesive Sensors.

Primary Outcome Measures

Name	Time	Method
Accuracy of Sensor by Arms Calculation	1-5 hours	Accuracy willl be determined by comparing the noninvasive hemoglobin measurement of the pulse oximeter to the hemoglobin value obtained from a blood sample and calculating the arithmetic root mean square(Arms) error value.

Trial Locations

Locations (1)

Masimo; 🇺🇸 Irvine, California, United States