Accuracy of Noninvasive Hemoglobin Sensor (Rainbow Reusable DCI)

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Device: Hemoglobin Sensor ((Rainbow Reusable DCI, DCIP))

• 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

Arm && Interventions

Group	Intervention	Description
Noninvasive Hemoglobin Sensor	Hemoglobin Sensor ((Rainbow Reusable DCI, DCIP))	All subjects are enrolled into the test group and all subjects received the Noninvasive Hemoglobin Sensor (Rainbow Reusable DCI, DCIP)

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