Accuracy of Hemoglobin Measurement for Various Rainbow Pulse Oximeter Sensors
1 other identifier
interventional
118
1 country
2
Brief Summary
In this study, the concentration of hemoglobin within the subject's blood will be reduced in a controlled manner by administering fluids intravenously. The accuracy of a noninvasive hemoglobin sensor(s) will be assessed by comparison to hemoglobin measurements from a laboratory analyzer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable healthy
Started Dec 2009
Shorter than P25 for not_applicable healthy
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 9, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2009
CompletedFirst Submitted
Initial submission to the registry
April 14, 2017
CompletedFirst Posted
Study publicly available on registry
April 24, 2017
CompletedResults Posted
Study results publicly available
June 6, 2017
CompletedJuly 27, 2017
June 1, 2017
22 days
April 14, 2017
May 8, 2017
June 28, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
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.
1-3 hours
Study Arms (1)
Noninvasive Hemoglobin Sensor
EXPERIMENTALAll subjects are enrolled into the test group and all will receive the pulse oximeter sensor.
Interventions
Eligibility Criteria
You may qualify if:
- Has physical status between ASA 1 or 2
- Able to communicate in English
You may not qualify if:
- 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 Raynaud's syndrome
- Hypertension: Systolic BP \>= 140 mmHg or Diastolic BP \>= 90 mmHg
- Baseline heart rate \<50 beats per minute
- Study Site 2:
- Male or female
- years of age
- Physical status of ASA I or II
- +16 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Masimo Clinical Lab
Irvine, California, 92618, United States
Loma Linda University Medical Center
Loma Linda, California, 92354, United States
Results Point of Contact
- Title
- Vikram Ramakanth
- Organization
- Masimo
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 14, 2017
First Posted
April 24, 2017
Study Start
December 9, 2009
Primary Completion
December 31, 2009
Study Completion
December 31, 2009
Last Updated
July 27, 2017
Results First Posted
June 6, 2017
Record last verified: 2017-06