OximetryNCT03710980
Accuracy of Pulse Oximeters With Profound Hypoxia
An observational study of Oximetry, run by Hancock Medical, Inc. at 1 site in United States.
Trial summary
This study to assess the oxygen saturation accuracy of the Beddr SleepTuner in profound hypoxia. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Oximetry
- What is being tested?
- Oximeter
- Type of treatment
- Medical device
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Sep 2018to 19 Sep 2018
- 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: Healthy adult volunteers.
Who may be able to join
- The subject is male or female, aged ≥18 and <50.
- The subject is in good general health with no evidence of any medical problems.
- The subject is fluent in both written and spoken English.
- The subject has provided informed consent and is willing to comply with the study procedures.
Who cannot join
- The subject is obese (BMI>30).
- The subject has a 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.
- The subject a hemoglobinopathy or history of anemia, per subject report or the first bloodsample, that in the opinion of the investigator, would make them unsuitable for study participation.
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- The subject has any other serious systemic illness.
- The subject is a current smoker.
- Any injury, deformity, or abnormality at the sensor sites that in the opinion of the investigators' would interfere with the sensors working correctly.
- The subject has a history of fainting or vasovagal response.
- The subject has a history of sensitivity to local anesthesia.
- The subject has a diagnosis of Raynaud's disease.
- The subject has unacceptable collateral circulation based on exam by the investigator (Allen's test).
- The subject is pregnant, lactating or trying to get pregnant.
- The subject is unable or unwilling to provide informed consent, or is unable or unwilling to comply with study procedures.
- The 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.
About this study
This study to assess the oxygen saturation accuracy of the Beddr SleepTuner in profound hypoxia.
- Conditions
- Oximetry
- Being tested
- Oximeter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OximeterDevice
Participants breathe a controlled gas mixture to induce several reduced oxygen states while oximeter measurements are taken for comparison to corresponding arterial blood draw samples to assess oximeter accuracy.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Adult Volunteer | Not described Receives: Device: Oximeter |
What is being measured
The primary outcome is the main question the study is designed to answer.
SpO2 Accuracy
Collect and analyze data to determine SpO2 accuracy of oximeters under test.
Measured: 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2018
- Study start18 Sep 2018
- Primary completion19 Sep 2018
- Study completion19 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OximetryStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hancock Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03710980
- Sponsor's protocol ID
- BEDD01
- Status last verified
- Oct 2018
- First submitted
- 16 Oct 2018
- Last updated
- 18 Oct 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy of Pulse Oximeters With Profound Hypoxia
- ClinicalTrials.gov ID
- NCT03710980
- Acronym / sponsor ID
- BEDD01
- Conditions
- Oximetry
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Hancock Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- 18 Sep 2018 (actual)
- Primary completion
- 19 Sep 2018 (actual)
- Study completion
- 19 Sep 2018 (actual)
- First posted
- 18 Oct 2018 (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.
This study to assess the oxygen saturation accuracy of the Beddr SleepTuner in profound hypoxia.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy Adult Volunteer | – | Device: Oximeter |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy adult volunteers.
Key inclusion criteria (4 listed)
- The subject is male or female, aged ≥18 and <50.
- The subject is in good general health with no evidence of any medical problems.
- The subject is fluent in both written and spoken English.
- The subject has provided informed consent and is willing to comply with the study procedures.
Key exclusion criteria (16 listed)
- The subject is obese (BMI>30).
- The subject has a 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 |
|---|---|---|
| OximeterParticipants breathe a controlled gas mixture to induce several reduced oxygen states while oximeter measurements are taken for comparison to corresponding arterial blood draw samples to assess oximeter accuracy. | Device | Healthy Adult Volunteer |
Primary outcome
SpO2 Accuracy
Time frame: 60 minutes
Collect and analyze data to determine SpO2 accuracy of oximeters under test.
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 18 Oct 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Oximetry, run by Hancock Medical, Inc. 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 16 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 18 Oct 2018. 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?
SpO2 Accuracy (time frame: 60 minutes). 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 18 Oct 2018.