Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
10 participants
INTERVENTIONAL
2022-04-26
2022-04-29
Brief Summary
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A minimum of 10 healthy adult male and female participants, ranging in age and pigmentation from light to dark, will be enrolled in the study to meet the study design requirements defined by International Organization for Standardization ISO 80601-2-61:2017: corrected version 2018-02 and by the FDA's Guidance for Pulse Oximeters (March 4, 2013). The participants will have an arterial catheter placed in the radial artery to allow for simultaneous blood samples during stable plateaus of induced hypoxic levels.
The investigational device will be placed on the placed on the thorax of the participants (patch on the upper back and external electrode on the right pectoral) per the instructions for use. Simultaneous data collection will be set up for the system under test and control oximeter.
Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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Controled Hypoxia - Healthy Volunteers
Pulse Oximeter, Respiratory Rate, Heart Rate and Arterial line
Measurement of physiological parameters
Interventions
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Pulse Oximeter, Respiratory Rate, Heart Rate and Arterial line
Measurement of physiological parameters
Eligibility Criteria
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Inclusion Criteria
* Participant must have the ability to understand and provide written informed consent
* Participant is 18 to 50 years of age
* Participant must be willing and able to comply with study procedures and duration
* Participant is a non-smoker or who has not smoked within 2 days prior to the study
Exclusion Criteria
* Compromised circulation, injury, or physical malformation of fingers, wrist, hands, ears or forehead/skull or other sensor sites, tattoo, extensive moles, or freckles in the optical path which would limit the ability to test sites needed for the study. (Note: Certain malformations may still allow participants to participate if the condition is noted and would not affect the particular sites utilized.)
* Female participants that are actively trying to get pregnant or are pregnant (confirmed by positive urine pregnancy test unless the participant is known to be not of child-bearing potential).
* Smoker participants who have refrained will be screened for Carboxyhemoglobin (COHb) levels \>3% as assessed with a reference devie (Masimo Radical 7)
* Participants with known respiratory conditions (self-reported)
* Participants with known heart or cardiovascular conditions (self-reported, except for blood pressure and ECG review)
* Self-reported health conditions as identified in the Health Assessment Form (self-reported)
* Participants with known clotting disorders (self-reported)
* Participants with severe contact allergies to standard adhesives, silicon, latex or other materials found in pulse oximetry sensors, ECG electrodes, respiration monitor electrodes or other medical sensors (self-reported)
* Participants with severe allergies to iodine (only applicable if iodine is used)
* Participants with severe allergies to lidocaine (or similar pharmacological agents, e.g. Novocaine)
* Failure of the Perfusion Index Ulnar/Ulnar+Radial Ratio test (Ratio \< 0.4)
* Unwillingness or inability to remove colored nail polish from test digits.
* Unwillingness to have chest or other test sites shaved
* Other known health condition, should be considered upon disclosure in health assessment form
18 Years
50 Years
ALL
Yes
Sponsors
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Rhythm Diagnostic Systems
INDUSTRY
Responsible Party
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Locations
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Clinimark LLC
Louisville, Colorado, United States
Countries
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Other Identifiers
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PR 2022-466
Identifier Type: -
Identifier Source: org_study_id