Accuracy of Noninvasive Hemoglobin Sensor (Rainbow Reusable DCI)

Not Applicable

Completed

• Conditions: Healthy

• Registration Number: NCT03124758
• Lead Sponsor: Masimo Corporation

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-04-20
• Primary Completion: 2011-10-31
• Study Completion: 2011-10-31
• 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: 354

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Accuracy of Sensor by Arms Calculation	1-5 hours	Accuracy will 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 Corporation; 🇺🇸 Irvine, California, United States