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

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.

Study Overview

• Status: Completed
• Conditions: Healthy; Surgery
• Intervention / Treatment: Device: Rainbow DCI pulse oximeter sensor

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Irvine, California, United States, 92618
      • Masimo Clinical Lab
    • Loma Linda, California, United States, 92354
      • Loma Linda University Medical Center
  • Florida
    • Jacksonville, Florida, United States
      • Mayo Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Healthy Volunteers

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
• Baseline heart rate <50 beats per minute

Surgical Subjects

Inclusion Criteria:

• Age > 18 years old
• Scheduled for surgery requiring frequent schedule blood draws as a part of their routine care

Exclusion Criteria:

• Pregnant or lactating women
• Skin abnormalities at the planed application sites that would interfere with transilluminating the finger, or other measurement sites, like burns, scar tissue, nail polish, infections etc.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test Group; All subjects are enrolled into the test group and all subjects received the Rainbow DCI pulse oximeter sensor.	Device: Rainbow DCI pulse oximeter sensor

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accuracy of Sensor by Arms Calculation	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.	Up to 24 hours

Collaborators and Investigators

• Sponsor: Masimo Corporation

Study record dates

Study Major Dates

• Study Start (Actual): August 12, 2008
• Primary Completion (Actual): September 9, 2008
• Study Completion (Actual): September 9, 2008

Study Registration Dates

• First Submitted: April 14, 2017
• First Submitted That Met QC Criteria: April 20, 2017
• First Posted (Actual): April 24, 2017

Study Record Updates

• Last Update Posted (Actual): June 12, 2017
• Last Update Submitted That Met QC Criteria: May 8, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: TR-17412-TORP0001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes