The Accuracy of the Dormotech VLAB During Stable Hypoxia Plateaus

NCT06516809 | Completed FDA Device

• 1 other identifier: VLAB_SpO2_C_T_1
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

forehead; reflectance; SpO2 sensor

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

DormoTech Vlab SpO2 sensor DEVICE

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.

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Dormotech Medical: lead

Study Sites (1)

Vital Signs Research Group

San Francisco, California, 94107, United States

Location

Study Officials

• Gregg Stratmann, MD PhD

  Vital Signs Research Group, San Francisco, CA.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2024
• First Posted: July 24, 2024
• Study Start: May 15, 2024
• Primary Completion: May 16, 2024
• Study Completion: May 30, 2024
• Last Updated: July 24, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)