HypoxiaNCT03348189
SpO2 Hypoxia Accuracy Validation Study
An observational study of Hypoxia, run by Nonin Medical, Inc at 1 site in United States.
Trial summary
The primary objective of this study is to evaluate the % oxygen saturation by pulse oximetry accuracy of a combined pulse oximetry system which consists of a Nonin sensor ), an adaptor cable, and an oximetry system during non-motion conditions. 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
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2017to 3 Nov 2017
- 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: A minimum of 12 subjects will be enrolled. The subject population will include both male and female subjects with a variety of skin tones.
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 50 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 15Show fewer
- The subject is currently pregnant, is actively trying to get pregnant, or who has a positive urine pregnancy test on the day of the study
- 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
The primary objective of this study is to evaluate the % oxygen saturation by pulse oximetry accuracy of a combined pulse oximetry system which consists of a Nonin sensor ), an adaptor cable, and an oximetry system during non-motion conditions.
Read the detailed description
The primary objective of this study is to evaluate the %SpO2 accuracy of a combined pulse oximetry system which consists of a Nonin sensor ), an adaptor cable, and an oximetry system during non-motion conditions.
- 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 OximeterOther
Pulse Oximeter
| Study group | Role | What they receive |
|---|---|---|
| Observational | Healthy males and females Receives: Other: Pulse Oximeter |
What is being measured
The primary outcome is the main question the study is designed to answer.
SpO2 Hypoxia Accuracy Validation Study
Values from the test device will be compared to the values from co-oximetry to determine accuracy of the test device.
Measured: Through study completion, 3 months average
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2017
- Study start1 Nov 2017
- Primary completion3 Nov 2017
- Study completion3 Nov 2017
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
- Other
- Time perspective
- Other
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nonin Medical, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dena Raley, Study director, Clinimark, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03348189
- Sponsor's protocol ID
- QATP3093
- Status last verified
- Oct 2017
- First submitted
- 15 Nov 2017
- Last updated
- 20 Nov 2017
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SpO2 Hypoxia Accuracy Validation Study
- ClinicalTrials.gov ID
- NCT03348189
- Acronym / sponsor ID
- QATP3093
- Conditions
- Hypoxia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Nonin Medical, IncIndustry (pharma, biotech, devices)
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 3 Nov 2017 (actual)
- Study completion
- 3 Nov 2017 (actual)
- First posted
- 20 Nov 2017 (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 primary objective of this study is to evaluate the % oxygen saturation by pulse oximetry accuracy of a combined pulse oximetry system which consists of a Nonin sensor ), an adaptor cable, and an oximetry system during non-motion conditions.
Detailed description
The primary objective of this study is to evaluate the %SpO2 accuracy of a combined pulse oximetry system which consists of a Nonin sensor ), an adaptor cable, and an oximetry system during non-motion conditions.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational | – | Other: Pulse OximeterHealthy males and females |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- A minimum of 12 subjects will be enrolled. The subject population will include both male and female subjects with a variety of skin tones.
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 50 years of age (self-reported)
Key exclusion criteria (15 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 OximeterPulse Oximeter | Other | Observational |
Primary outcome
SpO2 Hypoxia Accuracy Validation Study
Time frame: Through study completion, 3 months average
Values from the test device will be compared to the values from co-oximetry to determine accuracy of the test device.
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 Nov 2017.
- 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.
Dena Raley study director
Clinimark, LLC
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 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 Nov 2017. 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?
SpO2 Hypoxia Accuracy Validation Study (time frame: Through study completion, 3 months average). 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 Nov 2017; AzTrials last refreshed its copy on 27 Oct 2026.