Comparison of Noninvasive Hemoglobin Disposable Sensors

NCT03125031 | Completed Results FDA Device

• 1 other identifier: TR26947-TP16847A
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Accuracy of Noninvasive Sensors 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. The accuracy results from both sensors will be assessed for equivalence

  1-5 hours

Study Arms (2)

Group- Sensor 1

EXPERIMENTAL

All subjects are enrolled into the test group and receive the Rainbow adhesive adult/pediatric sensors.

Device: Rainbow adhesive adult/pediatric sensor

Group- Sensor 2

EXPERIMENTAL

All subjects are enrolled into the test group and receive the Rainbow adhesive adult/neonatal sensors.

Device: Rainbow adhesive adult/neonatal sensor

Interventions

Rainbow adhesive adult/pediatric sensor DEVICE

Group- Sensor 1

Rainbow adhesive adult/neonatal sensor DEVICE

Group- Sensor 2

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Masimo Corporation: lead

Study Sites (1)

Masimo Clinical Lab

Irvine, California, 92618, United States

Location

Results Point of Contact

• Title: Tala Harake
• Organization: Masimo

studies@masimo.com

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• 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: July 10, 2014
• Primary Completion: July 25, 2014
• Study Completion: July 25, 2014
• Last Updated: July 27, 2017
• Results First Posted: June 6, 2017

Record last verified: 2017-06

Locations

US (1)