Status:
COMPLETED
RDS MultiSense® SpO2 Validation Study
Lead Sponsor:
Rhythm Diagnostic Systems
Conditions:
Hypoxia
Eligibility:
All Genders
18-50 years
Phase:
NA
Brief Summary
The purpose of this clinical study is to validate the oxygen saturation (SpO2) accuracy of the RDS MultiSense® Pulse Oximetry during non-motion conditions over the range of 70-100% arterial oxygen sat...
Eligibility Criteria
Inclusion
- 10-15 Adults with a minimum of 3 males and a minimum of 3 females, with the balance made up of either
- 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
- Participant is considered as being morbidly obese (defined as BMI \>39.5)
- 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
Key Trial Info
Start Date :
April 26 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 29 2022
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT05359328
Start Date
April 26 2022
End Date
April 29 2022
Last Update
December 19 2024
Active Locations (1)
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1
Clinimark LLC
Louisville, Colorado, United States, 80027