Prospective Study to Validate the Clinical Accuracy of the Norbert Device to Measure Oxygen Saturation

Sponsor

Norbert Health (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05685654

Collaborator

Duke University (Other)

Enrollment

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Healthy Hypoxia	Device: Norbert Device

Detailed Description

The study is a single center, prospective, non-randomized study to measure the accuracy of an investigational device compared to blood reference values. The design of the study will be conducted in accordance with the recommendations of ISO 80601-2-61:2011 Annex EE.2 Procedure for invasive laboratory testing on healthy volunteers. 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. The end goal is to show the SpO2 accuracy performance of the Norbert Device. It is expected that the Accuracy Root Mean Square (Arms) performance of pulse oximeters will meet a specification of 3.5 or better in non-motion conditions for the range of 70-100% SaO2 thereby demonstrating an acceptable SpO2 accuracy performance specification.

Study Design

Study Type:

Observational

Anticipated Enrollment :

15 participants

Observational Model:

Other

Time Perspective:

Prospective

Official Title:

Prospective Study to Validate the Clinical Accuracy of the Norbert Device to Measure Oxygen Saturation

Anticipated Study Start Date :

Mar 1, 2023

Anticipated Primary Completion Date :

Mar 1, 2023

Anticipated Study Completion Date :

Mar 1, 2023

Outcome Measures

Primary Outcome Measures

SpO2 root mean square accuracy of the Norbert Device [Up to 1 hour]
SpO2 root mean square accuracy will be calculated following FDA guidelines.
SpO2 bias of the Norbert Device [Up to 1 hour]
SpO2 bias calculation of the Norbert Device will follow the FDA guidelines for analyzing population mean bias, between-subject variance, and within-subject variance.
Bland-Altman plots with linear regression line and 95% upper and lower limits of agreement [Up to 1 hour]
A method comparison study will be analyzed with a Bland-Altman plot. This study will produce limits of agreement (LoA) and associated confidence intervals from the two measurements obtained on each subject. The conclusion that the two measurements are in agreement depends on whether the confidence intervals constructed from the data are within the boundaries set from the maximum allowable difference.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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 saturation less than 95% by pulse oximetry
Has a clinically significant abnormal EKG
Has a COHb greater than 3%, or MetHb greater than 2%
Students and Employees under the direct supervision of PI or Sub-I