HealthyNCT06516809
The Accuracy of the Dormotech VLAB During Stable Hypoxia Plateaus
An observational study of Healthy, run by Dormotech Medical at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- DormoTech Vlab SpO2 sensor
- Type of treatment
- Medical device
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 15 May 2024to 30 May 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
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
Who may be able to join
- 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
Who cannot join
- 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).
Show all 18Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Vital Signs Research Group
San Francisco, California, 94107
About this study
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).
Read the 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
- Being tested
- DormoTech Vlab SpO2 sensor
- Keywords
- forehead, reflectance, SpO2 sensor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DormoTech Vlab SpO2 sensorDevice
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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%.
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2024
- Study start15 May 2024
- Primary completion16 May 2024
- Study completion30 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dormotech Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gregg Stratmann, MD PhD, Principal investigator, Vital Signs Research Group, San Francisco, CA.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06516809
- Sponsor's protocol ID
- VLAB_SpO2_C_T_1
- Status last verified
- Jul 2024
- First submitted
- 15 Jul 2024
- Last updated
- 24 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Accuracy of the Dormotech VLAB During Stable Hypoxia Plateaus
- ClinicalTrials.gov ID
- NCT06516809
- Acronym / sponsor ID
- VLAB_SpO2_C_T_1
- Conditions
- Healthy
- Keywords
- forehead, reflectance, SpO2 sensor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Dormotech MedicalIndustry (pharma, biotech, devices)
- Study start
- 15 May 2024 (actual)
- Primary completion
- 16 May 2024 (actual)
- Study completion
- 30 May 2024 (actual)
- First posted
- 24 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DormoTech Vlab SpO2 sensorThe 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. | Device | – |
Primary outcome
Measurement of arterial HbO2 saturations from 100% down to 70%
Time frame: day 1
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%.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gregg Stratmann, MD PhD principal investigator
Vital Signs Research Group, San Francisco, CA.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by Dormotech Medical at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of arterial HbO2 saturations from 100% down to 70% (time frame: day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2024.