OxygenationNCT00298090
Evaluation of a Radial Arterial Line's Effect on StO2 Monitoring
An observational study of Oxygenation, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
Trial summary
Measuring tissue oxygen saturation (St02) in the thenar eminence is emerging as a measurement of resuscitation. However, no study to our knowledge has evaluated the effects of an arterial line in the radial artery supplying this muscle bed on St02. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oxygenation
- What is being tested?
- StO2 monitoring
- Type of treatment
- Medical device
- How many people
- 47 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2006to Mar 2008
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- No healthy volunteers
- Adult, Older adult
Study population: ICU patients wiht arterial lines
Who may be able to join
- Standard of care placement of arterial line
- 18 years of age or older
Who cannot join
- Pregnant females
- Nursing mothers
- Prisoners
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Evaluation of a Radial Arterial Line's Effect on StO2 Monitoring Using the InSpectra® Tissue Spectrometer
Measuring tissue oxygen saturation (St02) in the thenar eminence is emerging as a measurement of resuscitation. However, no study to our knowledge has evaluated the effects of an arterial line in the radial artery supplying this muscle bed on St02. This study will attempt to address the interaction between an arterial line and St02 monitoring in the thenar eminence. As most patients who require aggressive resuscitation will have an arterial line, it is important to understand what if any impact this will have on St02 in the same extremity.
- Conditions
- Oxygenation
- Being tested
- StO2 monitoring
- Keywords
- Oxygenation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
StO2 monitoringDevice
Also called external near infrared spectroscopy
placement of the StO2 device/ external noninvasive
| Study group | Role | What they receive |
|---|---|---|
| StO2 values | StO2 monitoring Receives: Device: StO2 monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tissue Oxygen Saturation (StO2) Measurement on the Extremity With a Radial Arterial Line
Using near-infrared spectroscopy, the external device recorded raw StO2 values every 3.5 seconds for approximately 5 minutes prior to and immediately following the insertion of a radial arterial catheter on the ipsilateral side. The raw values were then compiled into one-minute averages.
Measured: up to 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2006 (estimated)
- Study startJan 2006
- Primary completionMar 2008
- Study completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for OxygenationStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center at San AntonioThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lopez P Peter, M.D., Principal investigator, The University of Texas Health Science Center at San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00298090
- Sponsor's protocol ID
- 045-1502-319
- Other IDs
- 045-1502-319
- Status last verified
- Nov 2014
- First submitted
- 27 Feb 2006
- Last updated
- 26 Nov 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluation of a Radial Arterial Line's Effect on StO2 Monitoring Using the InSpectra® Tissue Spectrometer
- ClinicalTrials.gov ID
- NCT00298090
- Acronym / sponsor ID
- 045-1502-319
- Conditions
- Oxygenation
- Keywords
- Oxygenation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Study start
- Jan 2006
- Primary completion
- Mar 2008 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 1 Mar 2006 (estimated)
- Results
- Posted 2 Aug 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Measuring tissue oxygen saturation (St02) in the thenar eminence is emerging as a measurement of resuscitation. However, no study to our knowledge has evaluated the effects of an arterial line in the radial artery supplying this muscle bed on St02. This study will attempt to address the interaction between an arterial line and St02 monitoring in the thenar eminence. As most patients who require aggressive resuscitation will have an arterial line, it is important to understand what if any impact this will have on St02 in the same extremity.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| StO2 values | – | Device: StO2 monitoringStO2 monitoring |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- ICU patients wiht arterial lines
Key inclusion criteria (2 listed)
- Standard of care placement of arterial line
- 18 years of age or older
Key exclusion criteria (3 listed)
- Pregnant females
- Nursing mothers
- Prisoners
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 |
|---|---|---|
| StO2 monitoringAlso: external near infrared spectroscopyplacement of the StO2 device/ external noninvasive | Device | StO2 values |
Primary outcome
Tissue Oxygen Saturation (StO2) Measurement on the Extremity With a Radial Arterial Line
Time frame: up to 15 minutes
Using near-infrared spectroscopy, the external device recorded raw StO2 values every 3.5 seconds for approximately 5 minutes prior to and immediately following the insertion of a radial arterial catheter on the ipsilateral side. The raw values were then compiled into one-minute averages.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- device informationLink provided by the sponsor.
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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.
Lopez P Peter, M.D. principal investigator
The University of Texas Health Science Center at San Antonio
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 Oxygenation, run by The University of Texas Health Science Center at San Antonio 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 2 inclusion and 3 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 26 Nov 2014. 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?
Yes. Results are posted in the registry (first posted 2 Aug 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Tissue Oxygen Saturation (StO2) Measurement on the Extremity With a Radial Arterial Line (time frame: up to 15 minutes). 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 26 Nov 2014; AzTrials last refreshed its copy on 7 Nov 2026.