Comparison of Noninvasive Hemoglobin Disposable Sensors

NCT ID: NCT03125031

Last Updated: 2017-07-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-07-10
• Study Completion Date: 2014-07-25

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Group- Sensor 1

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

Group Type: EXPERIMENTAL

Rainbow adhesive adult/pediatric sensor

Intervention Type: DEVICE

Group- Sensor 2

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

Group Type: EXPERIMENTAL

Rainbow adhesive adult/neonatal sensor

Intervention Type: DEVICE

Interventions

Rainbow adhesive adult/pediatric sensor

Intervention Type: DEVICE

Rainbow adhesive adult/neonatal sensor

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Masimo Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Masimo Clinical Lab

Irvine, California, United States

Countries

United States

Other Identifiers

TR26947-TP16847A

Identifier Type: -

Identifier Source: org_study_id