HealthyNCT06460246
Pulse Oximeter Accuracy During Stable Hypoxia Plateaus
A study testing Pulse Oximeter in people with Healthy, run by Acurable Ltd. at 1 site in United States.
Trial summary
This project aims to test the accuracy of pulse oximeters in the range of arterial HbO2 saturations from 100% down to 70%. 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?
- Pulse Oximeter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jun 2024to 31 Jul 2024
- Phase
- Interventional
- 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
Who may be able to join
- Male or female, aged >= 18 and < 50.
- Subject in good general 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 procedures.
Who cannot join
- Subject is obese (BMI > 35).
- 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.
- Subject has 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.
Show all 16Show fewer
- Subject has any other serious systemic illness.
- 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.
- 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 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, L.L.C.
San Francisco, California, 94107
About this study
This project aims to test the accuracy of pulse oximeters in the range of arterial HbO2 saturations from 100% down to 70%.
Read the detailed description
This project aims to test the accuracy of pulse oximeters in the range of arterial HbO2 saturations from 100% down to 70%. This is done by comparing the pulse oximeter reading during brief, steady state hypoxia plateaus with a gold-standard measurement of blood oxyhaemoglobin saturation.
- Conditions
- Healthy
- Being tested
- Pulse Oximeter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulse OximeterDevice
The subjects will have a 22-gauge catheter inserted in the radial artery to measure the oxygen saturation of arterial blood and also wear pulse oximeters.
| Study group | Role | What they receive |
|---|---|---|
| Pulse Oximeter | Experimental | The subjects will have a 22-gauge catheter inserted in the radial artery to measure the oxygen saturation of arterial blood and also wear pulse oximeters. Receives: Device: Pulse Oximeter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance of the pulse oximeters against corresponding arterial blood oxygen saturation.
Performance of the pulse oximeters against corresponding arterial blood oxygen saturation.
Measured: 1-4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2024
- Study start25 Jun 2024
- Primary completion27 Jun 2024
- Study completion31 Jul 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Acurable Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06460246
- Sponsor's protocol ID
- Pro00077383
- Status last verified
- Aug 2024
- First submitted
- 11 Jun 2024
- Last updated
- 23 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulse Oximeter Accuracy During Stable Hypoxia Plateaus
- ClinicalTrials.gov ID
- NCT06460246
- Acronym / sponsor ID
- Pro00077383
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Acurable Ltd.Industry (pharma, biotech, devices)
- Study start
- 25 Jun 2024 (actual)
- Primary completion
- 27 Jun 2024 (actual)
- Study completion
- 31 Jul 2024 (actual)
- First posted
- 14 Jun 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.
This project aims to test the accuracy of pulse oximeters in the range of arterial HbO2 saturations from 100% down to 70%.
Detailed description
This project aims to test the accuracy of pulse oximeters in the range of arterial HbO2 saturations from 100% down to 70%. This is done by comparing the pulse oximeter reading during brief, steady state hypoxia plateaus with a gold-standard measurement of blood oxyhaemoglobin saturation.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pulse Oximeter | Experimental | Device: Pulse OximeterThe subjects will have a 22-gauge catheter inserted in the radial artery to measure the oxygen saturation of arterial blood and also wear pulse oximeters. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Male or female, aged >= 18 and < 50.
- Subject in good general 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 procedures.
Key exclusion criteria (16 listed)
- Subject is obese (BMI > 35).
- 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 |
|---|---|---|
| Pulse OximeterThe subjects will have a 22-gauge catheter inserted in the radial artery to measure the oxygen saturation of arterial blood and also wear pulse oximeters. | Device | Pulse Oximeter |
Primary outcome
Performance of the pulse oximeters against corresponding arterial blood oxygen saturation.
Time frame: 1-4 hours
Performance of the pulse oximeters against corresponding arterial blood oxygen saturation.
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 23 Aug 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.
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?
A study testing Pulse Oximeter in people with Healthy, run by Acurable Ltd. 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 23 Aug 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?
Performance of the pulse oximeters against corresponding arterial blood oxygen saturation. (time frame: 1-4 hours). 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 23 Aug 2024; AzTrials last refreshed its copy on 31 Oct 2026.