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CompletedNCT03435211Updated Sep 19, 2024Results posted

Desaturation Validation of INVSENSOR00006

An interventional study of INVSENSOR00006 in Healthy, sponsored by Masimo Corporation. Completed at 1 site in United States. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-09-19.

Sponsored by Masimo Corporation · Interventional and Other

Study type
Interventional
Enrollment
52
Allocation
Not applicable
Ages
18 Years to 50 Years
Sex
All
01

Study 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%. The subject will then be returned to inhaling room air.

02

Conditions studied

  • Healthy
03

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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 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 (ASA I or II) 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

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 open wounds, inflamed tattoos or piercings, visible healing wounds.
  • 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 year.
  • 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 a chronic neurological disease (i.e. multiple sclerosis, Huntington's Disease).
  • 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) that interferes with the subject's level of consciousness.
  • 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 Wolff-Parkinson-White Syndrome or Stokes-Adams Syndrome.
  • Subject who has taken anticoagulant medication within the last 30 days.
  • Subject has taken opioid pain medication within 24 hours of start of study.
  • 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, gallbladder, heart, appendix, major fracture repairs (involving plates/ screws), jaw surgery, urinary tract surgery, plastic 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 30 days.
  • 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.
  • Discretion of investigator/study staff.
04

Study design

Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
52 participants (actual)

Study arms

  • Experimental
    INVSENSOR00006

    All subjects consented are enrolled into the test group and received the INVSENSOR00006.

    Device: INVSENSOR00006

Interventions

  • DeviceINVSENSOR00006

    Noninvasive pulse oximeter sensor

05

What researchers measure

Primary outcomes

  1. Oxygen Saturation (SpO2) Accuracy of Sensor

    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.

    Time frame: 1-5 hours

06

Results

Posted Mar 30, 2021

Participant flow

Participant flow — Overall Study
MilestoneINVSENSOR00006
Started26
Completed25
Not completed1
Withdrew: Unable to achieve minimum desaturation level1

Outcome measures

PrimaryOxygen Saturation (SpO2) Accuracy of Sensor

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.

Time frame:
1-5 hours
Reported as:
Number · % of oxygen saturated hemoglobin
Oxygen Saturation (SpO2) Accuracy of Sensor
% of oxygen saturated hemoglobinINVSENSOR00006
Oxygen Saturation (SpO2) Accuracy of Sensor1.16

Adverse events

Collected over 1 to 5 hours. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
INVSENSOR000060/26 (0%)0/26 (0%)0/26 (0%)

Baseline characteristics

Age, Customized
Age, Customized(Participants)INVSENSOR00006
<18 years0
Between 18 to 50 years25
>50 years0
Sex: Female, Male
Sex: Female, Male(Participants)INVSENSOR00006
Female11
Male14
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)INVSENSOR00006
Asian or Pacific Islander3
Caucasian10
Black or African American6
Hispanic5
Native American1
07

Study locations

1 site
  • Masimo Corporation
    Irvine, California 92618, United States
08

References and documents

Study documents

  • Protocol and statistical analysis plan · Sep 25, 2017

Documents are hosted by the registry — open the source record to download them.

09

Registry details

Key details

Study ID
NCT03435211
Lead sponsor
Masimo Corporation
Responsible party
Sponsor
First posted
Feb 15, 2018
Start date
Jan 17, 2018
Primary completion
Feb 19, 2018
Completion
Feb 19, 2018
Results posted
Mar 30, 2021
Last update
Sep 19, 2024

Oversight

View the source record on ClinicalTrials.gov ↗

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