Clinical trial NCT03124966: Accuracy of Hemoglobin Measurement for Various Rainbow Pulse Oximeter Sensors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: Masimo Corporation
Sponsor class: INDUSTRY
First posted: 2017-04-24
Enrollment: 118
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


Eligibility 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

Primary outcomes:
measure: Accuracy of Sensor by Arms Calculation
timeFrame: 1-3 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Irvine
country: United States
facility: Masimo Clinical Lab
state: California
city: Loma Linda
country: United States
facility: Loma Linda University Medical Center
state: California
Study officials:
References: