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

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ClinicalTrials.gov Identifier: NCT03124693
Recruitment Status : Completed
First Posted : April 24, 2017
Results First Posted : June 12, 2017
Last Update Posted : June 12, 2017
Sponsor:
Information provided by (Responsible Party):
Masimo Corporation

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.

Condition or disease Intervention/treatment Phase
Healthy Surgery Device: Rainbow DCI pulse oximeter sensor Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Actual Study Start Date : August 12, 2008
Actual Primary Completion Date : September 9, 2008
Actual Study Completion Date : September 9, 2008

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



Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03124693


Locations
United States, California
Masimo Clinical Lab
Irvine, California, United States, 92618
Loma Linda University Medical Center
Loma Linda, California, United States, 92354
United States, Florida
Mayo Clinic
Jacksonville, Florida, United States
Sponsors and Collaborators
Masimo Corporation

Responsible Party: Masimo Corporation
ClinicalTrials.gov Identifier: NCT03124693     History of Changes
Other Study ID Numbers: TR-17412-TORP0001
First Posted: April 24, 2017    Key Record Dates
Results First Posted: June 12, 2017
Last Update Posted: June 12, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No