The Accuracy of the Dormotech VLAB During Stable Hypoxia Plateaus

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).

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Device: DormoTech Vlab SpO2 sensor

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).

• Study Type: Observational
• Enrollment (Actual): 12

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94107
      • Vital Signs Research Group

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

This was a prospective study with 12 healthy volunteers who met all the inclusion criteria and none of the exclusion criteria. Dormotech provided the investigational SpO2 sensors to conduct the evaluation with existing equipment at the site

Description

Inclusion Criteria:

• Subject is male or Subject is male or female, aged 18 and < 50.
• Subject is in good health with no evidence of any medical problems.
• Subject is fluent in both written and spoken English.
• Subject has provided informed consent and is willing to comply with the study procedure

Exclusion Criteria:

• Subject is obese (BMI >35).
• Subject has known history of heart disease, lung disease, kidney or liver disease.
• Diagnosis of asthma, sleep apnea, or use of CPAP.
• Subject has diabetes.
• Subject has a clotting disorder.
• Subject uses any anticoagulative medication (blood thinner).
• Subject has a hemoglobinopathy or history of anemia, per subject report or the first blood sample, that in the opinion of the investigator, would make them unsuitable for study participation.
• Subject has any other serious systemic illness.
• Subject is a current smoker.
• Subject with any injury, deformity, or abnormality at the sensor sites that in the opinion of the investigators would interfere with the sensors working correctly.
• Subject has a history of fainting or vasovagal response.
• Subject has a history of sensitivity to local anesthesia
• Subject has a diagnosis of Raynaud's disease
• Subject has claustrophobia
• Subject has unacceptable collateral circulation based on exam by the investigator (Allen's test).
• Subject is pregnant, lactating or trying to get pregnant.
• Subject is unable or unwilling to provide informed consent or is unable or unwilling to comply with study procedures.
• Subject has any other condition, which in the opinion of the investigators would make them unsuitable for the study.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measurement of arterial HbO2 saturations from 100% down to 70%	At the start of each testing cycle, one blood sample was taken while breathing room air. Subjects then breathed through a partial rebreathing circuit with a nose clip, a mixture of nitrogen, air and carbon dioxide to reach six different stable levels (plateaus) of oxyhemoglobin saturation between 70-100%.	day 1

Collaborators and Investigators

• Sponsor: Dormotech Medical
• Investigators: Principal Investigator: Gregg Stratmann, MD PhD, Vital Signs Research Group, San Francisco, CA.

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2024
• Primary Completion (Actual): May 16, 2024
• Study Completion (Actual): May 30, 2024

Study Registration Dates

• First Submitted: July 15, 2024
• First Submitted That Met QC Criteria: July 23, 2024
• First Posted (Actual): July 24, 2024

Study Record Updates

• Last Update Posted (Actual): July 24, 2024
• Last Update Submitted That Met QC Criteria: July 23, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: forehead; reflectance; SpO2 sensor
• Additional Relevant MeSH Terms: Signs and Symptoms, Respiratory; Hypoxia
• Other Study ID Numbers: VLAB_SpO2_C_T_1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No