Accuracy of Noninvasive Hemoglobin Sensor (Rainbow Reusable DCI)

Masimo logo

Masimo

Status

Completed

Conditions

Healthy

Treatments

Device: Hemoglobin Sensor ((Rainbow Reusable DCI, DCIP))

Study type

Interventional

Funder types

Industry

Identifiers

NCT03124758
TR24577-TP15879-TP14065

Details and patient eligibility

About

In this study, the accuracy of a noninvasive hemoglobin sensor(s) will be assessed by comparison to hemoglobin measurements from a laboratory hematology analyzer. Blood samples are collected from healthy volunteers who are enrolled in either a blood draw procedure or a hemodilution procedure wherein blood is repeatedly sampled as the concentration of hemoglobin is reduced in a controlled manner by administering fluids intravenously.

Enrollment

354 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

A. Hemodilution Test Procedure

Inclusion Criteria:

  • Weight of more than 110 lbs and less than 220 lbs.
  • Physical status of ASA I of II
  • Able to read and communicate in English
  • Has signed written informed consent
  • Female, non pregnant. Female subjects will be provided with a pregnancy test free of charge.

Exclusion Criteria

  • Age less than 18 yrs and greater than 35 years
  • Weight of less than 110 lbs or more than 220 lbs.
  • Hemoglobin less than 12 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.
  • 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
  • Discretion of investigator

B. Blood Draw Test Procedure

Inclusion Criteria:

-Subjects must understand and consent to be in the study.

Exclusion Criteria

  • Subjects less than 18 years of age.
  • Subjects who do not understand the study and the risks involved.
  • Anyone deemed ineligible by test personnel.

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

354 participants in 1 patient group

Noninvasive Hemoglobin Sensor
Experimental group
Description:
All subjects are enrolled into the test group and all subjects received the Noninvasive Hemoglobin Sensor (Rainbow Reusable DCI, DCIP)
Treatment:
Device: Hemoglobin Sensor ((Rainbow Reusable DCI, DCIP))

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems