Accuracy of Noninvasive Hemoglobin Sensor (Rainbow Reusable DCI)

NCT ID: NCT03124758

Last Updated: 2017-07-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 354 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-04-20
• Study Completion Date: 2011-10-31

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.

Conditions

Healthy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Noninvasive Hemoglobin Sensor

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

Group Type: EXPERIMENTAL

Hemoglobin Sensor ((Rainbow Reusable DCI, DCIP))

Intervention Type: DEVICE

Measurement of Noninvasive Hemoglobin (SpHb)

Interventions

Hemoglobin Sensor ((Rainbow Reusable DCI, DCIP))

Measurement of Noninvasive Hemoglobin (SpHb)

Intervention Type: DEVICE

Eligibility Criteria

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.

-Subjects must understand and consent to be in the study.

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

• Subjects less than 18 years of age.
• Subjects who do not understand the study and the risks involved.
• Anyone deemed ineligible by test personnel.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Masimo Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Masimo Corporation

Irvine, California, United States

Countries

United States

Other Identifiers

TR24577-TP15879-TP14065

Identifier Type: -

Identifier Source: org_study_id