HypoxemiaNCT06022523
Accuracy of Pulse Oximeters With Profound Hypoxia
A study testing Data acquisition using DT-400 pulse oximetry system in people with Hypoxemia, run by Consolidated Research, Inc. at 1 site in United States.
Trial summary
The goal of this clinical trial is the acquisition of photoplethysmography signals during periods of profound hypoxia. The study is designed in accordance with ISO 80601- 2-61,2ed:2017-12 \& 2018-02. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypoxemia
- What is being tested?
- Data acquisition using DT-400 pulse oximetry system
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Nov 2022to 9 Nov 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- -
Who cannot join
- Pregnancy -
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Consolidated Research, Inc.
Cleveland, Ohio, 44132
Richard Kaplan, Ph.D., 216-289-2331, kaplan@cri-systems.com
About this study
The goal of this clinical trial is the acquisition of photoplethysmography signals during periods of profound hypoxia. The study is designed in accordance with ISO 80601- 2-61,2ed:2017-12 \& 2018-02.
- Conditions
- Hypoxemia
- Being tested
- Data acquisition using DT-400 pulse oximetry system
- Keywords
- Hypoxia, Pulse oximetry
- Medical subject headings
- Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data acquisition using DT-400 pulse oximetry systemDiagnostic test
Acquisition of photopleth data during profound hypoxia using a Consolidated Research DT-400 pulse oximetry system.
| Study group | Role | What they receive |
|---|---|---|
| Acquisition | Experimental | Subjects will undergo profound hypoxia with stable plateaus. Receives: Diagnostic Test: Data acquisition using DT-400 pulse oximetry system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Saturation level measurement
Induction of hypoxia by having subjects breathe mixtures of nitrogen, room air, and carbon dioxide to allow measurement of oxyhemoglobin saturation between 70-100%. Each plateau level of oxyhemoglobin saturation was maintained for at least 30 seconds or until reference pulse oximeters readings were stable
Measured: Within 12 months of subject recruitment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2023
- Study start9 Nov 2022
- Primary completion9 Nov 2024 (estimated)
- Study completion9 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypoxemiaStudies 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Consolidated Research, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06022523
- Sponsor's protocol ID
- 21-344376
- Status last verified
- Aug 2023
- First submitted
- 30 Nov 2022
- Last updated
- 5 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2023. 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
- NCT06022523
- Acronym / sponsor ID
- 21-344376
- Conditions
- Hypoxemia
- Keywords
- Hypoxia, Pulse oximetry
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Consolidated Research, Inc.Industry (pharma, biotech, devices)
- Study start
- 9 Nov 2022 (actual)
- Primary completion
- 9 Nov 2024 (estimated)
- Study completion
- 9 Nov 2024 (estimated)
- First posted
- 5 Sep 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.
The goal of this clinical trial is the acquisition of photoplethysmography signals during periods of profound hypoxia. The study is designed in accordance with ISO 80601- 2-61,2ed:2017-12 \& 2018-02.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acquisition | Experimental | Diagnostic Test: Data acquisition using DT-400 pulse oximetry systemSubjects will undergo profound hypoxia with stable plateaus. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- -
Key exclusion criteria (1 listed)
- Pregnancy -
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 |
|---|---|---|
| Data acquisition using DT-400 pulse oximetry systemAcquisition of photopleth data during profound hypoxia using a Consolidated Research DT-400 pulse oximetry system. | Diagnostic test | Acquisition |
Primary outcome
Saturation level measurement
Time frame: Within 12 months of subject recruitment
Induction of hypoxia by having subjects breathe mixtures of nitrogen, room air, and carbon dioxide to allow measurement of oxyhemoglobin saturation between 70-100%. Each plateau level of oxyhemoglobin saturation was maintained for at least 30 seconds or until reference pulse oximeters readings were stable
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2023.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Data acquisition using DT-400 pulse oximetry system in people with Hypoxemia, run by Consolidated Research, 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 5 Sep 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Saturation level measurement (time frame: Within 12 months of subject recruitment). 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 5 Sep 2023.