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Clinical Trials/NCT03124966
NCT03124966CompletedNot Applicable

Accuracy of Hemoglobin Measurement for Various Rainbow Pulse Oximeter Sensors

Masimo Corporation2 sites in 1 country118 target enrollmentStarted: December 9, 2009Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
118
Locations
2
Primary Endpoint
Accuracy of Sensor by Arms Calculation
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Other
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •Study Site 1:
  • •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 Raynaud's syndrome
  • •Hypertension: Systolic BP >= 140 mmHg or Diastolic BP >= 90 mmHg
  • •Baseline heart rate <50 beats per minute
  • •Study Site 2:
  • •Inclusion Criteria:
  • •Male or female
  • •18-35 years of age
  • •Physical status of ASA I or II
  • •Able to read and communicate in English
  • •Has signed written informed consent
  • •If female, non pregnant. If female subject is currently sexually active and not on birth control they must have a negative pregnancy test prior to study enrollment.
  • •Exclusion Criteria
  • •Age less than 18 yrs and greater than 35 years
  • •Hemoglobin less than 12 g/dL
  • •ASA physical status of III, IV, or V
  • •Pregnant or sexually active without birth control
  • •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, lithium, 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 Raynauds 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

Arms & Interventions

Noninvasive Hemoglobin Sensor

Experimental

All subjects are enrolled into the test group and all will receive the pulse oximeter sensor.

Intervention: Pulse Oximeter sensor (Device)

Outcomes

Primary Outcomes

Accuracy of Sensor by Arms Calculation

Time Frame: 1-3 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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (2)

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