HypoxiaMotionNCT03156140
Pulse Oximeter Motion Study
A study testing Motion in people with Hypoxia, run by University of California, San Francisco.
Trial summary
Evaluate the performance of 4 pulse oximeters in 10 healthy adult volunteers with three motions compared to non-motion control at three arterial oxygen saturation target plateaus. 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?
- Motion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2016to 31 Aug 2016
- 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
- Exclusion Criteria: pediatric, cardiac or pulmonary condition. non-english speaking
- -
Who cannot join
None listed.
About this study
Official title: Four Types of Pulse Oximeters Accurately Detect Hypoxia During Low Perfusion and Motion
Evaluate the performance of 4 pulse oximeters in 10 healthy adult volunteers with three motions compared to non-motion control at three arterial oxygen saturation target plateaus.
Read the detailed description
Evaluate the performance of 4 pulse oximeters (Masimo Radical-7, Nihon-Koden OxyPal Neo, Nellcor N-600, and Philips Intellivue MP5) in 10 healthy adult volunteers. Three motions will be evaluated: tapping, pseudorandom, and volunteer-generated rubbing, adjusted to produce photoplethsmogram disturbance similar to arterial pulsation amplitude. During motion, inspired gases will be adjusted to achieve stable target plateaus of arterial oxygen saturation (SaO2) at 75%, 88%, and 100%. Pulse oximeter readings (SpO2) will be compared with SaO2 from simultaneous arterial blood samples
- Conditions
- Hypoxia
- Being tested
- Motion
- Medical subject headings
- Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MotionOther
Volunteer has motion on right hand while with continuous pulse oximetry during three oxygenation plateaus
| Study group | Role | What they receive |
|---|---|---|
| motion | Experimental | Right hand performs three different motion types Receives: Other: Motion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulse oximetry reading
Measured: immediate
Secondary outcomes (1)
Arterial Blood gas
Measured: immediate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2017
- Study start1 Jun 2016
- Primary completion31 Aug 2016
- Study completion31 Aug 2016
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.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- 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
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jennifer Lucero, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03156140
- Sponsor's protocol ID
- Pulse Motion
- Acronym
- Motion
- Status last verified
- May 2017
- First submitted
- 15 May 2017
- Last updated
- 17 May 2017
- 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 17 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Four Types of Pulse Oximeters Accurately Detect Hypoxia During Low Perfusion and Motion
- ClinicalTrials.gov ID
- NCT03156140
- Acronym / sponsor ID
- Motion / Pulse Motion
- Conditions
- Hypoxia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- 1 Jun 2016 (actual)
- Primary completion
- 31 Aug 2016 (actual)
- Study completion
- 31 Aug 2016 (actual)
- First posted
- 17 May 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.
Evaluate the performance of 4 pulse oximeters in 10 healthy adult volunteers with three motions compared to non-motion control at three arterial oxygen saturation target plateaus.
Detailed description
Evaluate the performance of 4 pulse oximeters (Masimo Radical-7, Nihon-Koden OxyPal Neo, Nellcor N-600, and Philips Intellivue MP5) in 10 healthy adult volunteers. Three motions will be evaluated: tapping, pseudorandom, and volunteer-generated rubbing, adjusted to produce photoplethsmogram disturbance similar to arterial pulsation amplitude. During motion, inspired gases will be adjusted to achieve stable target plateaus of arterial oxygen saturation (SaO2) at 75%, 88%, and 100%. Pulse oximeter readings (SpO2) will be compared with SaO2 from simultaneous arterial blood samples
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| motion | Experimental | Other: MotionRight hand performs three different motion types |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Exclusion Criteria: pediatric, cardiac or pulmonary condition. non-english speaking
- -
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| MotionVolunteer has motion on right hand while with continuous pulse oximetry during three oxygenation plateaus | Other | motion |
Primary outcome
Pulse oximetry reading
Time frame: immediate
1 secondary outcome
Arterial Blood gas
Time frame: immediate
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 17 May 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Motion in people with Hypoxia, run by University of California, San Francisco.
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 2 inclusion and 0 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 17 May 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Pulse oximetry reading (time frame: immediate). 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 17 May 2017.