Hemodilution Validation of INVSENSOR00026

NCT03677375 | Completed Results FDA Device

• 1 other identifier: TP-19466
• Study Type: interventional
• Target: 173
• 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 a noninvasive hemoglobin sensor will be assessed by comparison to hemoglobin measurements from a laboratory analyzer.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Accuracy of Noninvasive Hemoglobin Sensor 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. In order to obtain the Arms value, the blood sample hemoglobin value is subtracted from the pulse oximeter hemoglobin value for a number of samples, the average of this difference is computed as the bias. The standard deviation of the differences is computed as the precision. The square root of the sum of the squares of bias and precision is computed as the Arms Error value.

  1-5 hours

Study Arms (1)

Test Subject

EXPERIMENTAL

All subjects who are enrolled into the test group and participate in data collection receive the noninvasive INVSENSOR00026.

Device: INVSENSOR00026

Interventions

INVSENSOR00026 DEVICE

Noninvasive pulse oximeter sensor

Test Subject

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Subject weighs a minimum of 110 lbs and no more than 250 lbs unless subject is over 6 feet tall.
• Hemoglobin value is greater than or equal to 11 g/dL at time of screening
• Baseline heart rate ≥ 45 bpm and ≤ 85 bpm.
• CO value ≤ 2.0% FCOHb
• Subject has a physical status of ASA I or II (American Society of Anesthesiology Class I; Healthy subjects without any systemic disease at all. American Society of Anesthesiology Class II; subjects with mild systemic disease) as it applies to the systemic disease portion of the classification.
• Systolic Blood Pressure ≤ 140 mmHg and Diastolic Blood Pressure ≤ 90 mmHg.
• Subject is able to read and communicate in English and understands the study and risks involved.

You may not qualify if:

• Subject is pregnant
• Subject smokes (including e-cigarette use)
• Subject has a BMI \> 35 and has been classified as morbidly obese or at an increased risk for participation by a medical professional.
• Subject has a history of fainting (vasovagal), blacking out or losing consciousness during or after a blood draw.
• Subject has open wounds, inflamed tattoos or piercings, or any visible healing wounds.
• Subject has known drug or alcohol abuse or uses recreational drugs.
• Subject has experienced a head injury with loss of consciousness within the last year.
• Subject has taken anticoagulant medication within the last 30 days.
• Subject has any chronic bleeding disorders (i.e. hemophilia).
• Subject has any history of a stroke, myocardial infarction, heart attack, or seizures.
• Subject has any cancer or history of cancer (not including skin cancer).
• Subject has a chronic neurological disease (i.e. multiple sclerosis, Huntington's disease).
• Subject has any cardiac dysrhythmias (i.e. atrial fibrillation) and has not received clearance from their physician.
• Subject has known neurological and/or psychiatric disorder (i.e. schizophrenia, bipolar disorder) that interferes with the subject's level of consciousness.
• Subject has Wolff-Parkinson-White Syndrome or Stokes-Adams Syndrome

Sponsors & Collaborators

• Masimo Corporation: lead

Study Sites (1)

Masimo Corporation

Irvine, California, 92618, United States

Location

Results Point of Contact

• Title: Tala Harake
• Organization: Masimo

studies@masimo.com

9492977000

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2018
• First Posted: September 19, 2018
• Study Start: September 4, 2018
• Primary Completion: February 4, 2019
• Study Completion: February 4, 2019
• Last Updated: May 20, 2019
• Results First Posted: May 20, 2019

Record last verified: 2019-04

Locations

US (1)