Comparison of Noninvasive Hemoglobin Disposable Sensors

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Device: Rainbow adhesive adult/pediatric sensor; Device: Rainbow adhesive adult/neonatal sensor

• Registration Number: NCT03125031
• Lead Sponsor: Masimo Corporation

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 two noninvasive hemoglobin sensors will be assessed by comparison to hemoglobin measurements from a laboratory analyzer.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-07-10
• Primary Completion: 2014-07-25
• Study Completion: 2014-07-25
• Study First Submitted: 2017-04-14
• Study First Submitted QC: 2017-04-20
• Study First Posted: 2017-04-24
• Results First Submitted: 2017-05-08
• Results First Submitted QC: 2017-05-08
• Status Verified: 2017-06
• Results First Posted: 2017-06-06
• Last Update Submitted: 2017-06-28
• Last Update Posted: 2017-07-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

• Male or female
• 18-40 years of age
• Weight of at least 110 lbs and less than 250 lbs for subjects under 6 feet tall.
• Physical status of ASA I of II
• Able to read and communicate in English
• Has signed written informed consent
• Female, non pregnant.

Exclusion Criteria

• Age less than 18 yrs and greater than 40 years
• If the Warming and cooling subjects have open cuts of skin abrasions on their extremities they will be excluded because alcohol spray may be painful.
• Weight of less than 110 lbs or more than 250 lbs if the subject is less than 6 feet tall.
• Hemoglobin less than 11 g/dL
• ASA physical status of III. IV, V.
• Pregnant
• 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, Lithum, 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 Reynauds Syndrome.
• Systolic BP >140 mmHg or Diastolic BP > 100 mmHg.
• Baseline heart rate < 50 bpm.
• Inability to tolerate sitting still or minimal movement for up to 90 minutes
• Discretion of investigator

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Group- Sensor 1	Rainbow adhesive adult/pediatric sensor	All subjects are enrolled into the test group and receive the Rainbow adhesive adult/pediatric sensors.
Group- Sensor 2	Rainbow adhesive adult/neonatal sensor	All subjects are enrolled into the test group and receive the Rainbow adhesive adult/neonatal sensors.

Primary Outcome Measures

Name	Time	Method
Accuracy of Noninvasive Sensors by Arms Calculation	1-5 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. The accuracy results from both sensors will be assessed for equivalence

Trial Locations

Locations (1)

Masimo Clinical Lab; 🇺🇸 Irvine, California, United States