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The Accuracy of the Dormotech VLAB During Stable Hypoxia Plateaus

NCT06516809 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 12

Last updated 2024-07-24

No results posted yet for this study

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).

Conditions

  • Healthy

Interventions

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.

Sponsors & Collaborators

  • Dormotech Medical

    lead INDUSTRY

Principal Investigators

  • Gregg Stratmann, MD PhD · Vital Signs Research Group, San Francisco, CA.

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-05-15
Primary Completion
2024-05-16
Completion
2024-05-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06516809 on ClinicalTrials.gov