Comparison of Rainbow INVSENSOR00001 and Control SpHb Disposable Sensor Performance During Hemodilution

NCT03273166 | Completed Results FDA Device

• 1 other identifier: TP-18788
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

Brief Summary

This study involves comparison of the performance of two SpHb sensors in subjects that undergo a hemodilution procedure. The sensors' performance will be assessed by comparison of the measured hemoglobin values against reference values obtained by a laboratory hematology analyzer. Blood samples will be collected from healthy volunteers who undergo a hemodilution procedure wherein blood is repeatedly sampled as the concentration of hemoglobin is reduced by administering intravenous fluids to the volunteer in a controlled manner.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Comparison of INVSENSOR00001 and Control SpHb Sensor by ARMS Calculation

  Performance of the sensors will be determined by comparing the noninvasive hemoglobin measurement (SpHb) of the pulse oximeter sensors to the hemoglobin value obtained from a reference blood sample and calculating the accuracy root mean square(ARMS) value.

  1-5 hours

Study Arms (1)

INVSENSOR00001 sensor

EXPERIMENTAL

This is a nonrandomized single arm study wherein all subjects are enrolled into the experimental arm and receive both the INVSENSOR00001 sensor and the control sensor simultaneously on different fingers.

Device: INVSENSOR00001; Device: Control SpHb sensor; Procedure: Hemodilution

Interventions

INVSENSOR00001 DEVICE

This is a non-randomized single arm study wherein all subjects are enrolled into the experimental arm and receive both the INVSENSOR00001 sensor and the control sensor simultaneously on different fingers.

INVSENSOR00001 sensor

Control SpHb sensor DEVICE

This is a non-randomized single arm study wherein all subjects are enrolled into the experimental arm and receive both the INVSENSOR00001 sensor and the control sensor simultaneously on different fingers.

INVSENSOR00001 sensor

Hemodilution PROCEDURE

This is a non-randomized single arm study wherein all subjects are enrolled into the experimental arm and receive both the INVSENSOR00001 sensor and the control sensor simultaneously on different fingers while undergoing a hemodilution procedure.

INVSENSOR00001 sensor

Eligibility Criteria

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

You may qualify if:

• Competent adults between the ages of 18 and 50 years of age
• Must weigh a minimum of 110 lbs and no more than 250 lbs unless subject is over 6 feet tall
• BMI ≤ 35 unless the physician determines that a higher BMI is not due to morbid obesity, to safeguard subject safety during hemodilution
• Must have a hemoglobin value ≥ 11 g/dL at time of screening, to safeguard subject safety during hemodilution
• Baseline heart rate between 45 bpm and 85 bpm
• CO value less than 2.0% FCOHb
• 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) The ASA definition strictly applies to the systemic disease portion of the classification
• Systolic BP less than or equal to 140 mmHg and Diastolic BP less than or equal to 90 mmHg
• Able to read and communicate in English

You may not qualify if:

• Pregnancy or positive hCG test
• Smokers (including e-cigarette users)
• Subject has known drug or alcohol abuse. Subjects who uses recreational drugs
• Subject has experienced a concussion or head injury with loss of consciousness within the last year
• Any chronic bleeding disorders (i.e. hemophilia)
• Any history of a stroke, myocardial infarction, or seizures
• Any cancer or history of cancer (not including skin cancer)
• Chronic neurological diseases (i.e. multiple sclerosis, Huntington's Disease)
• Any cardiac dysrhythmias (i.e. atrial fibrillation)(without physicians clearance)
• 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
• Subjects who have/are currently taking anticoagulant medication
• Subjects who have taken opioid pain medication within 24 hours of start of study
• Subjects who do not understand the study and the risks
• Subjects having either signs or history of peripheral ischemia

Sponsors & Collaborators

• Masimo Corporation: lead

Study Sites (1)

Masimo Clinical Lab

Irvine, California, 92618, United States

Location

MeSH Terms

Interventions

Hemodilution

Intervention Hierarchy (Ancestors)

Therapeutics

Results Point of Contact

• Title: Chelsea Frank
• Organization: Masimo

studies@masimo.com

(949) 297-7000

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 1, 2017
• First Posted: September 6, 2017
• Study Start: August 29, 2017
• Primary Completion: September 18, 2017
• Study Completion: September 18, 2017
• Last Updated: October 26, 2020
• Results First Posted: October 26, 2020

Record last verified: 2020-10

Locations

US (1)