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Desaturation Validation of INVSENSOR00031

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: NCT03783780
Recruitment Status : Completed
First Posted : December 21, 2018
Results First Posted : July 2, 2019
Last Update Posted : July 2, 2019
Sponsor:
Information provided by (Responsible Party):
Masimo Corporation

Brief Summary:
This study is designed to compare the accuracy of a noninvasive measurement of oxygen saturation compared to reference values obtained by a laboratory blood gas analyzer. Arterial blood samples will be collected from healthy adult subjects while undergoing a desaturation procedure wherein the concentration of oxygen inhaled is slowly reduced until the subject's arterial oxygen concentration is approximately 70%. During the desaturation, the subject's hand and arm without the arterial line will be subjected to motion at various times during the study. The subject will then be returned to breathing room air.

Condition or disease Intervention/treatment Phase
Healthy Device: INVSENSOR00031 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Desaturation Validation of INVSENSOR00031
Actual Study Start Date : December 11, 2018
Actual Primary Completion Date : December 18, 2018
Actual Study Completion Date : December 18, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy

Arm Intervention/treatment
Experimental: INVSENSOR00031
All subjects who are enrolled into the test group and participate in data collection receive the noninvasive INVSENSOR00031 sensor during motion and non-motion.
Device: INVSENSOR00031
Noninvasive pulse oximeter sensor




Primary Outcome Measures :
  1. Oxygen Saturation (SpO2) Accuracy of Sensor by Arms Calculation During Non-motion [ Time Frame: 1-5 hours ]
    Performance of the sensors will be determined by comparing the noninvasive oxygen saturation measurement (SpO2) of the pulse oximeter sensors to the arterial oxygen saturation (SaO2) value obtained from a reference blood sample and calculating the Arithmetic root mean square (ARMS) value during non-motion.


Secondary Outcome Measures :
  1. Oxygen Saturation (SpO2) Accuracy of Sensor by Arms Calculation During Motion [ Time Frame: 1-5 hours ]
    Performance of the sensors will be determined by comparing the noninvasive oxygen saturation measurement (SpO2) of the pulse oximeter sensors to the arterial oxygen saturation (SaO2) value obtained from a reference blood sample and calculating the Arithmetic root mean square (ARMS) value during motion.



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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 is 18-50 years of age.
  • 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.
  • Baseline heart rate ≥ 45 bpm and ≤ 85 bpm.
  • Carbon monoxide (CO) value ≤ 2.0% fractional carboxyhemoglobin (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 (smoking includes 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 blood draw, or has a fear of blood draws.
  • Subject has open wounds, inflamed tattoos or piercings, or any visible healing wounds that a medical professional renders them at an increased risk for participation.*
  • Subject experiences frequent or severe headaches and/or migraine headaches.
  • Subject has known drug or alcohol abuse and/or use of recreational drugs.
  • Subject has experienced a concussion or head injury with loss of consciousness within the last 12 months.
  • Subject has any chronic bleeding disorders (i.e. hemophilia).
  • Subject has any history of a stroke, myocardial infarction, seizures or heart attack.
  • Subject has any cancer or history of cancer (not including skin cancer).*
  • Subject has any cardiac dysrhythmia(s) (i.e. atrial fibrillation) and has not received clearance by their physician to participate.
  • Subject has a known neurological and/or psychiatric disorder (i.e. schizophrenia, bipolar disorder, Multiple Sclerosis, Huntington's Disease) that interferes with the subject's level of consciousness.
  • Subject has Wolff-Parkinson-White Syndrome or Stokes-Adams Syndrome.
  • Subject who has taken anticoagulant medication within the last 30 days (excluding nonsteroidal anti-inflammatory drugs (NSAIDS)).
  • Subject has taken opioid pain medication 24 hours before the 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.
  • Subject has had invasive surgery within the past year- including but not limited to major dental surgery*, appendix*, plastic surgery*.
  • Subject has had invasive surgery within the past year- including but not limited to gallbladder, heart, major fracture repairs (involving plates/ screws), jaw surgery, urinary tract surgery, major ears, nose and throat (ENT) surgery, joint replacement or gynecological surgeries, heart surgery or thoracic surgery.
  • Subject has donated blood within the past 4 weeks.
  • Subject has symptoms of congestion, head colds, flu or other illnesses.
  • Subject experiences claustrophobia 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 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 given vaginal delivery, had a pregnancy terminated, a miscarriage with hospitalization, or had a C-section within the last 6 months.
  • Subject intends to participate 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 of the study.
  • Subject has any medical condition which in the judgment of the investigator and/or medical staff, renders them ineligible for participation in this study or subject is deemed ineligible by the discretion of the investigator/study.

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): NCT03783780


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: NCT03783780     History of Changes
Other Study ID Numbers: TP-19564
First Posted: December 21, 2018    Key Record Dates
Results First Posted: July 2, 2019
Last Update Posted: July 2, 2019
Last Verified: June 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