Accuracy of Noninvasive Hemoglobin Measurement (SpHb) Using Rainbow DCI Pulse Oximeter Sensor

Masimo Corporation3 sites in 1 country90 target enrollmentAugust 12, 2008

ConditionsHealthy Surgery

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Healthy
Sponsor: Masimo Corporation
Enrollment: 90
Locations: 3
Primary Endpoint: Accuracy of Sensor by Arms Calculation
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

In this study, the concentration of hemoglobin within the subject's blood is affected by fluid status changes. The fluid status is affected by fluid loss during surgery for hospitalized study subjects or controlled administration of fluids intravenously for healthy study volunteers. The accuracy of a noninvasive hemoglobin sensor(s) will be assessed by comparing with blood sample analysis.

Registry

clinicaltrials.gov

Start Date

August 12, 2008

End Date

September 9, 2008

Last Updated

8 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Masimo Corporation

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Has physical status between ASA 1 or 2
•Able to communicate in English

Exclusion Criteria

•Pregnant or sexually active without birth control.
•Hemoglobin less than 11g/dL
•Known alcohol or drug abuse
•Skin abnormalities affecting the digits such as psoriasis, eczema, angioma, scar tissue, burn, fungal infection
•Nail polish
•Head injury with loss of consciousness within the last year
•Known neurological and psychiatric conditions.
•Known concurrent chronic usage of psychoactive or anti-convulsive drugs within the last 90 days, or use in the last 7 days (i.e. tricyclic antidepressants, MAO inhibitors, lithium, neuroleptics, anxiolytics or antipsychotics. Except SSRIs
•Subject has any medical condition which, in the judgement 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

Outcomes

Primary Outcomes

Accuracy of Sensor by Arms Calculation

Time Frame: Up to 24 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.