HypoxiaNCT05693168
Accuracy of Pulse Oximeter With Profound Hypoxia
A study testing ANNE Limb Sensor in people with Hypoxia, run by Sibel Health Inc. at 1 site in United States.
Trial summary
Clinical evaluation of the accuracy of SpO2 measurements with the ANNE Limb Sensor compared to blood gas analysis in healthy, adult subjects. Hypoxia is induced in patients to different and stable levels of SaO2 over the range of 70-100%. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypoxia
- What is being tested?
- ANNE Limb Sensor
- 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
- 23 Jun 2021to 24 Jun 2021
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- The subject is male or female, between the ages of 18 and 55 years.
- 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
- 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 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
- The subject has any other serious systemic illness
Show all 15Show fewer
- Th 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.
United States1 site
Hypoxia Research Laboratory Department of Anesthesia and Perioperative Care University of California, San Francisco
San Francisco, California, 94143
About this study
Clinical evaluation of the accuracy of SpO2 measurements with the ANNE Limb Sensor compared to blood gas analysis in healthy, adult subjects. Hypoxia is induced in patients to different and stable levels of SaO2 over the range of 70-100%.
- Conditions
- Hypoxia
- Being tested
- ANNE Limb Sensor
- Medical subject headings
- Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ANNE Limb SensorDevice
Pulse Oximeter
| Study group | Role | What they receive |
|---|---|---|
| Comparison of ANNE Limb Sensor pulse oximetry measurements to blood gas analysis | Experimental | Not described Receives: Device: ANNE Limb Sensor |
What is being measured
The primary outcome is the main question the study is designed to answer.
ARMS of SpO2 Measurements with ANNE Limb compared to SaO2
Root mean square error between the function blood oxygen saturation (SpO2) provided by the device under test and the blood gas analysis of oxyhemoglobin saturation (SaO2)
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2023
- Study start23 Jun 2021
- Primary completion24 Jun 2021
- Study completion24 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypoxiaStudies 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sibel Health Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05693168
- Sponsor's protocol ID
- SIBE01
- Status last verified
- Jan 2023
- First submitted
- 27 Dec 2022
- Last updated
- 20 Jan 2023
- Results posted
- 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 20 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy of Pulse Oximeter With Profound Hypoxia
- ClinicalTrials.gov ID
- NCT05693168
- Acronym / sponsor ID
- SIBE01
- Conditions
- Hypoxia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Sibel Health Inc.Industry (pharma, biotech, devices)
- Study start
- 23 Jun 2021 (actual)
- Primary completion
- 24 Jun 2021 (actual)
- Study completion
- 24 Jun 2021 (actual)
- First posted
- 20 Jan 2023 (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.
Clinical evaluation of the accuracy of SpO2 measurements with the ANNE Limb Sensor compared to blood gas analysis in healthy, adult subjects. Hypoxia is induced in patients to different and stable levels of SaO2 over the range of 70-100%.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Comparison of ANNE Limb Sensor pulse oximetry measurements to blood gas analysis | Experimental | Device: ANNE Limb Sensor |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- The subject is male or female, between the ages of 18 and 55 years.
- 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 (15 listed)
- 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 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
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 |
|---|---|---|
| ANNE Limb SensorPulse Oximeter | Device | Comparison of ANNE Limb Sensor pulse oximetry measurements to blood gas analysis |
Primary outcome
ARMS of SpO2 Measurements with ANNE Limb compared to SaO2
Time frame: 1 hour
Root mean square error between the function blood oxygen saturation (SpO2) provided by the device under test and the blood gas analysis of oxyhemoglobin saturation (SaO2)
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 20 Jan 2023.
- 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 ANNE Limb Sensor in people with Hypoxia, run by Sibel Health 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 15 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 20 Jan 2023. 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?
ARMS of SpO2 Measurements with ANNE Limb compared to SaO2 (time frame: 1 hour). 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 20 Jan 2023.