HypoxiaNCT02475668
SpO2 Accuracy Validation of Pulse Oximetry Systems During Motion and Non-Motion Conditions
An observational study of Hypoxia, run by Nonin Medical, Inc at 1 site in United States.
Trial summary
Study to evaluate the %SpO2 accuracy performance of the Nonin Medical pulse oximetry systems. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypoxia
- What is being tested?
- Pulse oximeter
- Type of treatment
- Medical device
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2015to Jun 2015
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Healthy volunteers
Who may be able to join
- The subject is male or female
- The subject is of any racial or ethnic group
- The subject is > 30 kg (>66 pounds) in weight (self-reported)
- The subject has at least one finger height of 0.2 - 1.0 inch (based on measurement)
- The subject is between 18 years and 45 years of age (self=reported)
- The subject shows no evidence of medical problems as indicated by satisfactory completion of the health assessment form
- The subject has given written informed consent to participate in the study
- The subject is both willing and able to comply with study procedures.
Who cannot join
- The subject has a BMI greater than 31 (based on weight and height)
- The subject has had any relevant injury at the sensor location site (self-reported)
- The subject has deformities or abnormalities that may prevent proper application of the device under test (based on examination)
- The subject is current smoker (self-reported)
- The subject has a known respiratory condition (self-reported)
- The subject has a known heart or cardiovascular condition (self-reported)
Show all 16Show fewer
- The subject is currently pregnant (self-reported)
- The subject is actively trying to get pregnant (self-reported)
- The subject has a clotting disorder (self-reported)
- The subject has Raynaud's Disease (self-reported)
- The subject is known to have a hemoglobinopathy (self-reported)
- The subject is on blood thinners or medication with aspirin (self-reported)
- The subject has unacceptable collateral circulation from the ulnar artery (based on examination)
- The subject is unwilling or unable to provide written informed consent to participate in the study
- The subject is unwilling or unable to comply with the study procedures
- The subject has another health condition which in the opinion of the principal investigator makes him/her unsuitable for testing.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: SpO2 Accuracy Validation of Pulse Oximetry Systems During Motion and Non-Motion Conditions of Induced Hypoxia as Compared to Arterial Blood CO-Oximetry
Study to evaluate the %SpO2 accuracy performance of the Nonin Medical pulse oximetry systems.
Read the detailed description
Study to evaluate the %SpO2 accuracy performance of the Nonin Medical pulse oximetry systems during motion and non-motion.
- Conditions
- Hypoxia
- Being tested
- Pulse oximeter
- Medical subject headings
- Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulse oximeterDevice
Hypoxia
What is being measured
The primary outcome is the main question the study is designed to answer.
accuracy value (Arms) for %SpO2 over the range of 70-100% in motion and non-motion
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2015 (estimated)
- Study startJun 2015
- Primary completionJun 2015
- Study completionJun 2015
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nonin Medical, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Clinimark, LLC
- Responsible party
- Sponsor
- Investigators
- Dave Ransom, MD, Principal investigator, Avista Adventis Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02475668
- Sponsor's protocol ID
- QATP2759
- Status last verified
- Jul 2015
- First submitted
- 16 Jun 2015
- Last updated
- 10 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SpO2 Accuracy Validation of Pulse Oximetry Systems During Motion and Non-Motion Conditions of Induced Hypoxia as Compared to Arterial Blood CO-Oximetry
- ClinicalTrials.gov ID
- NCT02475668
- Acronym / sponsor ID
- QATP2759
- Conditions
- Hypoxia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Nonin Medical, IncIndustry (pharma, biotech, devices)
- Collaborators
- Clinimark, LLC
- Study start
- Jun 2015
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 19 Jun 2015 (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.
Study to evaluate the %SpO2 accuracy performance of the Nonin Medical pulse oximetry systems.
Detailed description
Study to evaluate the %SpO2 accuracy performance of the Nonin Medical pulse oximetry systems during motion and non-motion.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy volunteers
Key inclusion criteria (8 listed)
- The subject is male or female
- The subject is of any racial or ethnic group
- The subject is > 30 kg (>66 pounds) in weight (self-reported)
- The subject has at least one finger height of 0.2 - 1.0 inch (based on measurement)
- The subject is between 18 years and 45 years of age (self=reported)
Key exclusion criteria (16 listed)
- The subject has a BMI greater than 31 (based on weight and height)
- The subject has had any relevant injury at the sensor location site (self-reported)
- The subject has deformities or abnormalities that may prevent proper application of the device under test (based on examination)
- The subject is current smoker (self-reported)
- The subject has a known respiratory condition (self-reported)
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 oximeterHypoxia | Device | – |
Primary outcome
accuracy value (Arms) for %SpO2 over the range of 70-100% in motion and non-motion
Time frame: 3 days
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 10 Jul 2015.
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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.
Dave Ransom, MD principal investigator
Avista Adventis 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 Nonin Medical, 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 8 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 10 Jul 2015. 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 value (Arms) for %SpO2 over the range of 70-100% in motion and non-motion (time frame: 3 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 10 Jul 2015.