HealthyNCT01746576
Use of Near Infrared Spectroscopy to Measure Intracranial ScvO2
A study testing Use of impedance threshold device during spontaneous ventilation in people with Healthy, run by University of Virginia at 1 site in United States.
Trial summary
The purpose of this study is to determine whether analysis of near infrared absorbance signals that occur at different frequencies might provide information about the difference in oxygen saturation between arterial and venous blood. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Use of impedance threshold device during spontaneous ventilation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2012to Sep 2013
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult 18-65 years of age
Who cannot join
- Dilated cardiomyopathy
- Congestive heart failure
- Pulmonary hypertension
- Severe aortic stenosis
- Flail chest
- Chest pain
- Shortness of breath
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Virginia
Charlottesville, Virginia, 22908
About this study
The purpose of this study is to determine whether analysis of near infrared absorbance signals that occur at different frequencies might provide information about the difference in oxygen saturation between arterial and venous blood.
- Conditions
- Healthy
- Being tested
- Use of impedance threshold device during spontaneous ventilation
- Keywords
- volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of impedance threshold device during spontaneous ventilationOther
| Study group | Role | What they receive |
|---|---|---|
| All | Other | All subjects will undergo spontaneous ventilation through an impedance threshold device and ScvO2 will be recorded before and after Receives: Other: Use of impedance threshold device during spontaneous ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Estimated venous oxygen saturation
Oxygen saturation will be calculated from the five minute period of time prior to use of the impedance threshold device (0-4 mins), and then again in the 2 minute period after the impedance threshold device is applied (5-6 mins)
Measured: From 5 to 6:59 minutes after applying the impedance threshold device
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2012 (estimated)
- Study startSep 2012
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert Thiele, MD, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01746576
- Sponsor's protocol ID
- 16422
- Status last verified
- Dec 2012
- First submitted
- 29 Oct 2012
- Last updated
- 16 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Thiele RH, Tucker-Schwartz JM, Lu Y, Gillies GT, Durieux ME. Transcutaneous regional venous oximetry: a feasibility study. Anesth Analg. 2011 Jun;112(6):1353-7. doi: 10.1213/ANE.0b013e3182166a26.
PubMed 21613200
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Near Infrared Spectroscopy to Measure Intracranial ScvO2
- ClinicalTrials.gov ID
- NCT01746576
- Acronym / sponsor ID
- 16422
- Conditions
- Healthy
- Keywords
- volunteers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 11 Dec 2012 (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 determine whether analysis of near infrared absorbance signals that occur at different frequencies might provide information about the difference in oxygen saturation between arterial and venous blood.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All | Other | Other: Use of impedance threshold device during spontaneous ventilationAll subjects will undergo spontaneous ventilation through an impedance threshold device and ScvO2 will be recorded before and after |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult 18-65 years of age
Key exclusion criteria (7 listed)
- Dilated cardiomyopathy
- Congestive heart failure
- Pulmonary hypertension
- Severe aortic stenosis
- Flail chest
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 |
|---|---|---|
| Use of impedance threshold device during spontaneous ventilation | Other | All |
Primary outcome
Estimated venous oxygen saturation
Time frame: From 5 to 6:59 minutes after applying the impedance threshold device
Oxygen saturation will be calculated from the five minute period of time prior to use of the impedance threshold device (0-4 mins), and then again in the 2 minute period after the impedance threshold device is applied (5-6 mins)
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 16 Apr 2014.
- Background: PubMed 21613200Thiele RH, Tucker-Schwartz JM, Lu Y, Gillies GT, Durieux ME. Transcutaneous regional venous oximetry: a feasibility study. Anesth Analg. 2011 Jun;112(6):1353-7. doi: 10.1213/ANE.0b013e3182166a26.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Use of impedance threshold device during spontaneous ventilation in people with Healthy, run by University of Virginia 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 1 inclusion and 7 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 16 Apr 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?
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?
Estimated venous oxygen saturation (time frame: From 5 to 6:59 minutes after applying the impedance threshold device). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01746576, which also lists 1 linked publication.
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 16 Apr 2014.