Prospective Study to Validate the Clinical Accuracy of the Norbert Device to Measure Oxygen Satur… (NCT05685654) | Clinical Trial Compass
UnknownNot Applicable
Prospective Study to Validate the Clinical Accuracy of the Norbert Device to Measure Oxygen Saturation
15 participantsStarted 2023-03
Plain-language summary
The purpose of this study is to evaluate the SpO2 accuracy and performance of the Norbert Device during non-motion conditions over the range of 70-100% SaO2 as compared to arterial blood samples assessed by CO-oximetry for SpO2 validation.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Healthy, male or female subjects between the ages of 18 to 50 years
* Completion of a health screening for a medical history by a licensed physician, nurse practitioner, or physician assistant
* Previously measured hemoglobin electrophoresis with normal result recorded in Duke Epic EHR
* Minimum weight 40kg; BMI within range 18.0 - 35.0
* Assigned American Society of Anesthesiologists (ASA) Physical Status 1 by Principal Investigator or delegate
Exclusion Criteria:
* Prior or known allergies to lidocaine (or similar pharmacologic agents, e.g., Novocain)
* Prior known severe allergies to medical grade adhesive/tape (Band-Aid)
* Taking any medication other than birth control
* Is currently participating in, or has recently participated in (discontinued within 30 days prior to the hypoxia procedure for this study) in an investigational interventional drug, device, or biologic study
* Has a negative Allen's Test to confirm non patency of the collateral artery
* Has made a whole blood donation or has had at least 450 ml of blood drawn within 8 weeks prior to the study procedure
* Is female with a positive urine pregnancy test, or is female and is unwilling to use effective birth control between the time of screening and study procedure or is breast feeding
* Has anemia
* Has heparin allergy
* Has a history of sickle cell trait or thalassemia \[self-reported\]
* Has a positive urine cotinine test or urine drug screen or oral ethanol test
* Has a room air sa…
What they're measuring
1
SpO2 root mean square accuracy of the Norbert Device
Timeframe: Up to 1 hour
2
SpO2 bias of the Norbert Device
Timeframe: Up to 1 hour
3
Bland-Altman plots with linear regression line and 95% upper and lower limits of agreement