SpO2NCT05322382
Accuracy of Pulse Oximeters With Profound Hypoxia
A study testing A-line in people with SpO2, run by CardiacSense Ltd. at 1 site in United States.
Trial summary
This project aims to test the accuracy of pulse oximeters during mild, moderate, and severe hypoxia, i.e., a range of arterial HbO2 saturation from 100 down to 70%. A typical study will include at least ten subjects (at least 200 necessary data points to meet the ISO 80601-2-61:2017). Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- SpO2
- What is being tested?
- A-line
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jun 2021to 3 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California at San Francisco
San Francisco, California, 94143
About this study
Official title: Accuracy of Pulse Oximeters With Profound Hypoxia - Test Protocol
This project aims to test the accuracy of pulse oximeters during mild, moderate, and severe hypoxia, i.e., a range of arterial HbO2 saturation from 100 down to 70%. A typical study will include at least ten subjects (at least 200 necessary data points to meet the ISO 80601-2-61:2017).
Read the detailed description
After local anesthetic injection, a 22-gauge catheter is inserted in one radial artery. Pulse oximeters are attached to fingers, ears, or flat body surfaces. Subjects are in a comfortable semi-recumbent position. Subjects then breathe air mixtures containing reduced amounts of oxygen to produce the desired level of hypoxemia. Stable, safe, and controlled hypoxia is breath-by-breath by breath respiratory gas analysis and a computer program that permits the inspired gas mixture to be adjusted to achieve a level of lung alveolar gas that will achieve the desired degree of saturation.
- Conditions
- SpO2
- Being tested
- A-line
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A-lineProcedure or surgery
Also called Hypoxemia
Subjects breathe air mixtures containing reduced amounts of oxygen to produce the desired level of hypoxemia.
| Study group | Role | What they receive |
|---|---|---|
| Single | Experimental | Subjects undergo an interventional procedure and non-invasive measurements of SpO2. Receives: Procedure: A-line |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of pulse oximeter with profound hypoxia
Perform accurate measurement of a range of arterial HbO2 saturation from 100 to down to 70% during mild, moderate, and severe hypoxia.
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2022
- Study start2 Jun 2021
- Primary completion3 Jun 2021
- Study completion3 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SpO2Studies 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
- CardiacSense Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Philip Bickler, MD, Principal investigator, UCSF Hypoxia Lab
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05322382
- Sponsor's protocol ID
- 008_SPO_CV_OS_USF
- Status last verified
- Apr 2022
- First submitted
- 4 Apr 2022
- Last updated
- 18 Apr 2022
- 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 18 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy of Pulse Oximeters With Profound Hypoxia - Test Protocol
- ClinicalTrials.gov ID
- NCT05322382
- Acronym / sponsor ID
- 008_SPO_CV_OS_USF
- Conditions
- SpO2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- CardiacSense Ltd.Industry (pharma, biotech, devices)
- Study start
- 2 Jun 2021 (actual)
- Primary completion
- 3 Jun 2021 (actual)
- Study completion
- 3 Jun 2021 (actual)
- First posted
- 11 Apr 2022 (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 during mild, moderate, and severe hypoxia, i.e., a range of arterial HbO2 saturation from 100 down to 70%. A typical study will include at least ten subjects (at least 200 necessary data points to meet the ISO 80601-2-61:2017).
Detailed description
After local anesthetic injection, a 22-gauge catheter is inserted in one radial artery. Pulse oximeters are attached to fingers, ears, or flat body surfaces. Subjects are in a comfortable semi-recumbent position. Subjects then breathe air mixtures containing reduced amounts of oxygen to produce the desired level of hypoxemia. Stable, safe, and controlled hypoxia is breath-by-breath by breath respiratory gas analysis and a computer program that permits the inspired gas mixture to be adjusted to achieve a level of lung alveolar gas that will achieve the desired degree of saturation.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single | Experimental | Procedure: A-lineSubjects undergo an interventional procedure and non-invasive measurements of SpO2. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
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 (5 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 |
|---|---|---|
| A-lineAlso: HypoxemiaSubjects breathe air mixtures containing reduced amounts of oxygen to produce the desired level of hypoxemia. | Procedure or surgery | Single |
Primary outcome
Accuracy of pulse oximeter with profound hypoxia
Time frame: 2 days
Perform accurate measurement of a range of arterial HbO2 saturation from 100 to down to 70% during mild, moderate, and severe hypoxia.
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 Apr 2022.
- Individual participant dataSharing planned: No
Related trials for SpO2
RecruitingObservational study
Development and Validation of a Multimodal Deep Learning Model Using Peripheral Oxygen Saturation and Ballistocardiography Signals for Predicting Apnea-Hypopnea Index in Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingObservational study
Comparison of Pulse Oximetry (SpO2) With Different Oximeters and Arterial Saturation (SaO2): Oxygap2 Study
Respiratory Failure, Hypoxemia
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
Recruiting
Transoral Nasal Cannula Oxygen Therapy for Mouth-Breathing Patients in the Postanesthesia Care Unit
Postoperative Hypoxemia
RecruitingObservational study
Finger Versus Earlobe Pulse Oximetry During the 6-Minute Walk Test in Interstitial Lung Disease
Interstitial Lung Disease (ILD), Idiopathic Pulmonary Fibrosis (IPF)
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.
Philip Bickler, MD principal investigator
UCSF Hypoxia Lab
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A-line in people with SpO2, run by CardiacSense 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 5 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 Apr 2022. 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?
Accuracy of pulse oximeter with profound hypoxia (time frame: 2 days). 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 Apr 2022.