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

NCT05685654 | Unknown

• 1 other identifier: NCP-0003
• Study Type: observational
• Target: 15
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Healthy; Hypoxia

Keywords

medical device; validation; hypoxia; SpO2; oxygen saturation; Norbert Device; Norbert Health

Outcome Measures

Primary Outcomes (3)

• SpO2 root mean square accuracy of the Norbert Device

  SpO2 root mean square accuracy will be calculated following FDA guidelines.

  Up to 1 hour

• SpO2 bias of the Norbert Device

  SpO2 bias calculation of the Norbert Device will follow the FDA guidelines for analyzing population mean bias, between-subject variance, and within-subject variance.

  Up to 1 hour

• Bland-Altman plots with linear regression line and 95% upper and lower limits of agreement

  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.

  Up to 1 hour

Interventions

Norbert Device DEVICE

The Norbert Device (ND) is a contactless, noninvasive device that provides measurements of body temperature, oxygen saturation (SpO2), and pulse rate.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Up to 15 healthy, adult volunteers, aged 18 - 50, will be enrolled. The subjects will be distributed across both genders as equally as practical and with a range of skin pigmentation.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Norbert Health: lead
• Duke University: collaborator

MeSH Terms

Conditions

Hypoxia

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Ellie Gonzalez

CONTACT

503-400-17222; ellie@norberthealth.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2023
• First Posted: January 17, 2023
• Study Start: March 1, 2023
• Primary Completion: March 1, 2023
• Study Completion: March 1, 2023
• Last Updated: January 23, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share