HypoxiaNCT01253772
Pulse Oximeter Responses to Multiple Levels of Stable Hypoxia in Neonates
An observational study of Hypoxia, run by SterilMed, Inc..
Trial summary
Validate pulse oximeter sensors in neonates by comparing sensor readings to blood samples during cardiac surgery. Read more about this study
- Who is it for?
- Ages Up to 6 months
- Conditions the study is for
- Hypoxia
- How many people
- 4 participants
- Where
- No sites listed yet
- Study dates
- May 2010to Aug 2010
- 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 Up to 6 months
- All sexes
- No healthy volunteers
- Child
Study population: Neonatal children undergoing complex cardiac surgical procedures.
Who may be able to join
- Neonatal patient scheduled to undergo cardiac surgery where routine blood draws would be taken
- Understand and provide signed parental/guardian consent
Who cannot join
- Failure to obtain parental consent
- Patients shown to have an adverse reaction to medical tape/adhesive
About this study
Validate pulse oximeter sensors in neonates by comparing sensor readings to blood samples during cardiac surgery.
Read the detailed description
Researchers at the University of California, San Francisco have developed methods that permit them to test multiple pulse oximeter sensors on neonates simultaneously during cardiac surgery. During this type of surgery, the arterial oxygen saturation changes over a wide range, providing an ideal arena for the assessment of neonatal pulse oximeter sensors at many levels of oxygen saturation. Several arterial blood gas samples are typically obtained during these procedures. Saturation of each arterial blood sample is determined by direct oximetry in a hemoximeter and this measurement is compared to the reading displayed on the pulse oximeter.
- Conditions
- Hypoxia
- Medical subject headings
- Hypoxia
What is being measured
The primary outcome is the main question the study is designed to answer.
SpO2 Accuracy Verification Study (ARMS) of ≤ 3%
Measured: During Analysis - data were collected anywhere from the beginning of surgery until the completion of the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2010 (estimated)
- Study startMay 2010
- Primary completionAug 2010
- Study completionAug 2010
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
- Time perspective
- Prospective
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- SterilMed, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Greg Stratmann, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01253772
- Sponsor's protocol ID
- STER01P
- Status last verified
- Dec 2010
- First submitted
- 1 Dec 2010
- Last updated
- 3 Dec 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulse Oximeter Responses to Multiple Levels of Stable Hypoxia in Neonates
- ClinicalTrials.gov ID
- NCT01253772
- Acronym / sponsor ID
- STER01P
- Conditions
- Hypoxia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- SterilMed, Inc.Industry (pharma, biotech, devices)
- Study start
- May 2010
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 3 Dec 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.
Validate pulse oximeter sensors in neonates by comparing sensor readings to blood samples during cardiac surgery.
Detailed description
Researchers at the University of California, San Francisco have developed methods that permit them to test multiple pulse oximeter sensors on neonates simultaneously during cardiac surgery. During this type of surgery, the arterial oxygen saturation changes over a wide range, providing an ideal arena for the assessment of neonatal pulse oximeter sensors at many levels of oxygen saturation. Several arterial blood gas samples are typically obtained during these procedures. Saturation of each arterial blood sample is determined by direct oximetry in a hemoximeter and this measurement is compared to the reading displayed on the pulse oximeter.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 6 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Neonatal children undergoing complex cardiac surgical procedures.
Key inclusion criteria (2 listed)
- Neonatal patient scheduled to undergo cardiac surgery where routine blood draws would be taken
- Understand and provide signed parental/guardian consent
Key exclusion criteria (2 listed)
- Failure to obtain parental consent
- Patients shown to have an adverse reaction to medical tape/adhesive
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
SpO2 Accuracy Verification Study (ARMS) of ≤ 3%
Time frame: During Analysis - data were collected anywhere from the beginning of surgery until the completion of the procedure
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 3 Dec 2010.
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Acute Intermittent Hypoxia Therapy for Depression
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RecruitingObservational study
Comparison of Pulse Oximetry (SpO2) With Different Oximeters and Arterial Saturation (SaO2): Oxygap2 Study
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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.
Greg Stratmann, MD principal investigator
University of California, San Francisco
Questions about this trial
What is this clinical trial studying?
An observational study of Hypoxia, run by SterilMed, Inc..
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 2 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 3 Dec 2010. 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?
SpO2 Accuracy Verification Study (ARMS) of ≤ 3% (time frame: During Analysis - data were collected anywhere from the beginning of surgery until the completion of the procedure). 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 3 Dec 2010.