NCT06516809

The Accuracy of the Dormotech VLAB During Stable Hypoxia Plateaus

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 12 (actual)
• Sponsor: Dormotech Medical · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

The purpose of the study is to determine the accuracy of the Dormotech VLAB (SpO2) Sensor in accordance with the FDA Guidance on Pulse Oximeters - Premarket Notification Submissions \[510(k)s\], in range of arterial HbO2 saturations from 100% down to 70%. This was a prospective study with healthy volunteers. The primary objective of the study was to determine the accuracy of the Dormotech VLAB sensor from saturations from 100 down to 70%. As the primary endpoint, the accuracy of the device during non-motion tests was determined by comparing the pulse oximeter reading during brief, steady-state hypoxia plateaus with a gold-standard measurement of blood oxyhemoglobin saturation (arterial blood sample processed in a multi-wavelength hemoximeter).

Detailed description

The purpose of the study is to determine the accuracy of the Dormotech VLAB (SpO2) Sensor in accordance with the FDA Guidance on Pulse Oximeters - Premarket Notification Submissions \[510(k)s\], in the range of arterial HbO2 saturations from 100% down to 70%. The subjects represent a diverse group in terms of age, height, weight, ethnicity, and skin types, which is beneficial for generalizing findings across different demographics. Subjects span all six types, indicating a wide range of skin types from very fair (Type I) to deeply pigmented dark (Type VI). This was a prospective study with healthy volunteers. The primary objective of the study was to determine the accuracy of the Dormotech VLAB sensor from saturations from 100 down to 70%. As the primary endpoint, the accuracy of the device during non-motion tests was determined by comparing the pulse oximeter reading during brief, steady-state hypoxia plateaus with a gold-standard measurement of blood oxyhemoglobin saturation (arterial blood sample processed in a multi-wavelength hemoximeter).

Conditions

• Healthy

Interventions

Type	Name	Description
DEVICE	DormoTech Vlab SpO2 sensor	The Dormotech Vlab sensor was applied to one of the subject's forehead. Reference pulse oximeters were applied to the right fingers. Blood gas analysis to determine hemoglobin saturation (SaO2) was performed using an ABL-90 Flex Plus multi-wavelength oximeter (Hemoximeter, Radiometer, Copenhagen). The ABL90 Flex Plus contains factory calibration standards and automatically performs regular quality controls.

Timeline

• Start date: 2024-05-15
• Primary completion: 2024-05-16
• Completion: 2024-05-30
• First posted: 2024-07-24
• Last updated: 2024-07-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study