HealthySPO2NCT01183338
Accuracy of Continuous SpO2 Measurement in Adults
An observational study of Healthy, run by Sotera Wireless, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to compare the accuracy of the Sotera ViSi, an investigational device, to standard devices in estimating the level of blood oxygen (SpO2) in adult human subjects. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy adult volunteers, male or female, of any ethnic background. To the extent possible while still achieving timely enrollment, subjects should vary from one another in their physical characteristics. Each subject must also meet all of the inclusion and exclusion criteria prior to study entry and give informed consent to participate in this study.
Who may be able to join
- Subject is at least 18 years of age.
- Subject is a healthy volunteer capable of undergoing controlled hypoxemia to the level of 70% SaO2 (±3%) with no or minimal medical risk.
- Subject is willing and able to participate in the measurement period for up to two hours.
Who cannot join
- Subject has a carboxyhemoglobin level (COHb) ≥3%.
- Subject has a MetHb level ≥2%.
- Subject has a ctHb value ≤10g/dl.
- Subject is in another clinical study that may interfere with the results of this study.
- Subject is unable or unwilling to have a blood gas and oxygen saturation measurements taken from either wrist/hand.
- Subject is deemed by the Investigator to be medically unsuitable for participation in this study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Clinimark Desaturation Laboratory
Louisville, Colorado, 80027
About this study
Official title: SpO2 Accuracy Validation of Sotera Wireless Pulse Oximetry Systems During Non-Motion and Motion Conditions of Induced Hypoxia as Compared to Arterial Blood CO-Oximetry
The purpose of this study is to compare the accuracy of the Sotera ViSi, an investigational device, to standard devices in estimating the level of blood oxygen (SpO2) in adult human subjects.
Read the detailed description
This study is a single-center blinded study that will enroll up to 15 adult subjects, male or female, of any ethnic background.
SpO2 and pulse rate measurements reported by ViSi will be compared with simultaneous measurements of blood SaO2 and pulse rate made by an FDA-cleared CO-oximeter and pulse oximeter, respectively. The paired measurements will be made in a well-controlled environment under optimal laboratory conditions.
- Conditions
- Healthy
- Keywords
- SpO2, Oxygen saturation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Time perspective
- Prospective
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sotera Wireless, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Philip S. Clifford, PhD, Principal investigator, VA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01183338
- Sponsor's protocol ID
- SWI-US11-006
- Acronym
- SPO2
- Status last verified
- Jun 2011
- First submitted
- 13 Aug 2010
- Last updated
- 22 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SpO2 Accuracy Validation of Sotera Wireless Pulse Oximetry Systems During Non-Motion and Motion Conditions of Induced Hypoxia as Compared to Arterial Blood CO-Oximetry
- ClinicalTrials.gov ID
- NCT01183338
- Acronym / sponsor ID
- SPO2 / SWI-US11-006
- Conditions
- Healthy
- Keywords
- SpO2, Oxygen saturation
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Sotera Wireless, Inc.Industry (pharma, biotech, devices)
- First posted
- 17 Aug 2010 (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 compare the accuracy of the Sotera ViSi, an investigational device, to standard devices in estimating the level of blood oxygen (SpO2) in adult human subjects.
Detailed description
This study is a single-center blinded study that will enroll up to 15 adult subjects, male or female, of any ethnic background.
SpO2 and pulse rate measurements reported by ViSi will be compared with simultaneous measurements of blood SaO2 and pulse rate made by an FDA-cleared CO-oximeter and pulse oximeter, respectively. The paired measurements will be made in a well-controlled environment under optimal laboratory conditions.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy adult volunteers, male or female, of any ethnic background. To the extent possible while still achieving timely enrollment, subjects should vary from one another in their physical characteristics. Each subject must also meet all of the inclusion and exclusion criteria prior to study entry and give informed consent to participate in this study.
Key inclusion criteria (3 listed)
- Subject is at least 18 years of age.
- Subject is a healthy volunteer capable of undergoing controlled hypoxemia to the level of 70% SaO2 (±3%) with no or minimal medical risk.
- Subject is willing and able to participate in the measurement period for up to two hours.
Key exclusion criteria (6 listed)
- Subject has a carboxyhemoglobin level (COHb) ≥3%.
- Subject has a MetHb level ≥2%.
- Subject has a ctHb value ≤10g/dl.
- Subject is in another clinical study that may interfere with the results of this study.
- Subject is unable or unwilling to have a blood gas and oxygen saturation measurements taken from either wrist/hand.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2011.
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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.
Philip S. Clifford, PhD principal investigator
VA Medical Center
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 Healthy, run by Sotera Wireless, 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 3 inclusion and 6 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: withdrawn, as of the sponsor's last update on 22 Jun 2011. 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 was withdrawn before enrolling participants, so there are no results.
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.
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 22 Jun 2011.