HypoxiaNCT00881829
Hypoxia Blood Validation in Multiple Pulse Oximeters
An observational study of Hypoxia, run by Clinimark, LLC at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the SpO2 accuracy and performance of multiple pulse oximeters during non-motion conditions over the range of 70-100% SaO2 as compared to arterial blood samples assessed by CO-Oximetry for SpO2 validation. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypoxia
- What is being tested?
- Pulse Oximeter, Blood Pressure, Respiratory Rate, Respiratory Gasses, Temperature
- Type of treatment
- Medical device
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Aug 2016to 21 Dec 2021
- 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: Residents of the Denver metropolitan area.
Who may be able to join
- healthy individuals between the age of 18-50 years.
Who cannot join
- Clotting disorders, diabetes, currently taking psychotropic medications.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Clinimark Laboratories
Louisville, Colorado, 80027
Paul B Batchelder, RRT, 303-717-4820, PBatchelder@Clinimark.com
Paul B Batchelder, RRT, LRCP
About this study
Official title: Accuracy Validation in Multiple SpO2 Systems
The purpose of this study is to evaluate the SpO2 accuracy and performance of multiple pulse oximeters during non-motion conditions over the range of 70-100% SaO2 as compared to arterial blood samples assessed by CO-Oximetry for SpO2 validation.
This study is observational in nature which quantifies device performance and accuracy in comparison to a Reference Standard.
Read the detailed description
The purpose of this study is to evaluate the SpO2 accuracy and performance of pulse oximeters during non-motion conditions over the range of 70-100% SaO2 as compared to arterial blood samples assessed by CO-Oximetry for SpO2 validation. The end goal is to show the SpO2 accuracy performance of the pulse oximeters. It is expected that the Accuracy Root Mean Square (Arms) performance of pulse oximeters will meet a specification of 3 or better in non-motion conditions for the range of 70-100% SaO2 thereby demonstrating an acceptable SpO2 accuracy performance specification
- Conditions
- Hypoxia
- Being tested
- Pulse Oximeter, Blood Pressure, Respiratory Rate, Respiratory Gasses, Temperature
- Keywords
- Pulse Oximetry, Temperature, Respiratory Rate, Respiratory Gases, This study determine the measurement accuracy of the physiological parameters
- Medical subject headings
- Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulse Oximeter, Blood Pressure, Respiratory Rate, Respiratory Gasses, TemperatureDevice
Measurement of physiological parameters.
| Study group | Role | What they receive |
|---|---|---|
| Healthy volunteer | Smoker or non-smoker Receives: Device: Pulse Oximeter, Blood Pressure, Respiratory Rate, Respiratory Gasses, Temperature |
What is being measured
The primary outcome is the main question the study is designed to answer.
Completion of study by all subjects
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2009 (estimated)
- Study start9 Aug 2016
- Primary completion21 Dec 2021 (estimated)
- Study completion21 Dec 2021 (estimated)
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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clinimark, LLC
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Ransom, MD, Clinimark, LLC
- Investigators
- David Ransom, MD, Principal investigator, Avista Adventist Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00881829
- Sponsor's protocol ID
- PR 2016-192 Rev 1
- Status last verified
- Feb 2021
- First submitted
- 13 Apr 2009
- Last updated
- 26 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy Validation in Multiple SpO2 Systems
- ClinicalTrials.gov ID
- NCT00881829
- Acronym / sponsor ID
- PR 2016-192 Rev 1
- Conditions
- Hypoxia
- Keywords
- Pulse Oximetry, Temperature, Respiratory Rate, Respiratory Gases, This study determine the measurement accuracy of the physiological parameters
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Clinimark, LLCUniversity, hospital or other
- Study start
- 9 Aug 2016 (actual)
- Primary completion
- 21 Dec 2021 (estimated)
- Study completion
- 21 Dec 2021 (estimated)
- First posted
- 15 Apr 2009 (estimated)
- 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 purpose of this study is to evaluate the SpO2 accuracy and performance of multiple pulse oximeters during non-motion conditions over the range of 70-100% SaO2 as compared to arterial blood samples assessed by CO-Oximetry for SpO2 validation.
This study is observational in nature which quantifies device performance and accuracy in comparison to a Reference Standard.
Detailed description
The purpose of this study is to evaluate the SpO2 accuracy and performance of pulse oximeters during non-motion conditions over the range of 70-100% SaO2 as compared to arterial blood samples assessed by CO-Oximetry for SpO2 validation. The end goal is to show the SpO2 accuracy performance of the pulse oximeters. It is expected that the Accuracy Root Mean Square (Arms) performance of pulse oximeters will meet a specification of 3 or better in non-motion conditions for the range of 70-100% SaO2 thereby demonstrating an acceptable SpO2 accuracy performance specification
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy volunteer | – | Device: Pulse Oximeter, Blood Pressure, Respiratory Rate, Respiratory Gasses, TemperatureSmoker or non-smoker |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Residents of the Denver metropolitan area.
Key inclusion criteria (1 listed)
- healthy individuals between the age of 18-50 years.
Key exclusion criteria (1 listed)
- Clotting disorders, diabetes, currently taking psychotropic medications.
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 Oximeter, Blood Pressure, Respiratory Rate, Respiratory Gasses, TemperatureMeasurement of physiological parameters. | Device | Healthy volunteer |
Primary outcome
Completion of study by all subjects
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2021.
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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.
David Ransom, MD principal investigator
Avista Adventist Hospital
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 Hypoxia, run by Clinimark, LLC 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 26 Feb 2021. 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?
Contact Dena M Raley, BSBE (303-249-6010, DMRaley@Clinimark.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Completion of study by all subjects (time frame: 5 years). 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 26 Feb 2021.