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Hemodilution Validation of INVSENSOR00026

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03677375
Recruitment Status : Completed
First Posted : September 19, 2018
Results First Posted : May 20, 2019
Last Update Posted : May 20, 2019
Sponsor:
Information provided by (Responsible Party):
Masimo Corporation

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.

Condition or disease Intervention/treatment Phase
Healthy Device: INVSENSOR00026 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 173 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Hemodilution Validation of INVSENSOR00026
Actual Study Start Date : September 4, 2018
Actual Primary Completion Date : February 4, 2019
Actual Study Completion Date : February 4, 2019

Arm Intervention/treatment
Experimental: Test Subject
All subjects who are enrolled into the test group and participate in data collection receive the noninvasive INVSENSOR00026.
Device: INVSENSOR00026
Noninvasive pulse oximeter sensor




Primary Outcome Measures :
  1. Accuracy of Noninvasive Hemoglobin Sensor by Arms Calculation [ Time Frame: 1-5 hours ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
  • Subject has any medical condition which in the judgment of the investigator and/or medical staff, renders them ineligible for participation in this study (Discretion of investigator).
  • Subject has taken opioid pain medication within 24 hours of start of study.
  • Subject has any type of infectious disease (i.e. Hepatitis, HIV, Tuberculosis, Flu, Malaria, Measles, etc.).
  • Subject is taking medications known to treat any type of infectious disease.
  • Subject has either signs or history of peripheral ischemia or carpal tunnel.
  • Subject has had invasive surgery within the past year- including but not limited to major dental surgery, gallbladder, heart, appendix, major fracture repairs (involving plates/ screws), jaw surgery, Urinary tract surgery, plastic surgery, major ENT surgery, joint replacement or gynecological surgeries, heart surgery or thoracic surgery.
  • Subject has symptoms of congestion, head colds, flu, or other illnesses
  • Subject has donated blood within the last 2 weeks.
  • Subject is claustrophobic or has generalized anxiety disorder.
  • Subject has been in severe car accident(s) or a similar type of accident(s) requiring hospitalization within the last 12 months.
  • Subject has had a concussion within the last 12 months.
  • Subject has chronic unresolved asthma, lung disease or respiratory disease.
  • Subject is allergic to lidocaine, latex, adhesives, or plastic.
  • Subject has heart conditions, insulin-dependent diabetes or uncontrolled hypertension.
  • Subject has delivered vaginally, has had a pregnancy terminated, a miscarriage with hospitalization, or had a C-section within the last 6 months.
  • Subject intends on participating in any heavy lifting, repetitive movement of their wrist (including riding a motorcycle) or exercise (working out, riding a bike, riding a skate board etc.), or any activity that will put additional stress on the wrist within 24 hours following a study that involves an arterial line.
  • Discretion of investigator/study staff

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03677375


Locations
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United States, California
Masimo Corporation
Irvine, California, United States, 92618
Sponsors and Collaborators
Masimo Corporation
  Study Documents (Full-Text)

Documents provided by Masimo Corporation:

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Responsible Party: Masimo Corporation
ClinicalTrials.gov Identifier: NCT03677375     History of Changes
Other Study ID Numbers: TP-19466
First Posted: September 19, 2018    Key Record Dates
Results First Posted: May 20, 2019
Last Update Posted: May 20, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No