Accuracy of Hemoglobin Measurement for Various Rainbow Pulse Oximeter Sensors

• ClinicalTrials.gov Identifier: NCT03124966
• Recruitment Status: Completed
• First Posted: April 24, 2017
• Results First Posted: June 6, 2017
• Last Update Posted: July 27, 2017
• Sponsor: Masimo Corporation
• Information provided by (Responsible Party): Masimo Corporation

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Healthy	Device: Pulse Oximeter sensor	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 118 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Actual Study Start Date: December 9, 2009
• Actual Primary Completion Date: December 31, 2009
• Actual Study Completion Date: December 31, 2009

Arms and Interventions

Arm	Intervention/treatment
Experimental: Noninvasive Hemoglobin Sensor; All subjects are enrolled into the test group and all will receive the pulse oximeter sensor.	Device: Pulse Oximeter sensor

Outcome Measures

Primary Outcome Measures :

1. 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.

Eligibility Criteria

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

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

Contacts and Locations

Locations

United States, California

Masimo Clinical Lab

Irvine, California, United States, 92618

Loma Linda University Medical Center

Loma Linda, California, United States, 92354

Sponsors and Collaborators

Masimo Corporation

More Information

• Responsible Party: Masimo Corporation
• ClinicalTrials.gov Identifier: NCT03124966
• Other Study ID Numbers: TR19443-56044
• First Posted: April 24, 2017
• Results First Posted: June 6, 2017
• Last Update Posted: July 27, 2017
• Last Verified: June 2017

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes