Brain InjuriesNCT00703495
Invasive and Non-Invasive Assessment of Cerebral Oxygenation in Patients With Severe Traumatic Brain Injury (TBI)
An observational study of Brain Injuries, run by Hospitales Universitarios Virgen del Rocío at 1 site in Spain.
Trial summary
The purpose of this study is to investigate the relationship among regional transcranial oxygen saturation (rSO2), brain tissue oxygen pressure (PbtO2) and cerebral perfusion pressure (CPP) in patients with severe traumatic brain injury (TBI). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Brain Injuries
- What is being tested?
- transcranial oxygen saturation measurement (INVOS Somanetics 5100C)
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteSpain
- Study dates
- Jul 2008to Apr 2009
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Stable patients with severe traumatic brain injury (Glasgow Coma Scale < 9) monitored through intracranial pressure (ICP) and brain tissue partial pressure of oxygen (PbtO2) probe, inserted for indications other than inclusion in this study
Who may be able to join
- Severe Traumatic Brain Injury (Glasgow Coma Scale < 9)
- Having an intraparenchymal cerebral ICP/PbtO2 catheter previously inserted.
- Expected length of ICU stay > 1 days
Who cannot join
- Patient's relatives refusal to patient's inclusion in the study
- Patients necessitating ongoing resuscitation
- End-stage in which death is imminent
- Deficient signal of rSO2 impeding its proper valuation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Validation of Non- Invasive Regional Transcranial Oxygen Saturation (rSO2) by Comparison With Invasive Brain Tissue Oxygenation (PbtO 2) Measurement in Patients With Severe Traumatic Brain Injury
The purpose of this study is to investigate the relationship among regional transcranial oxygen saturation (rSO2), brain tissue oxygen pressure (PbtO2) and cerebral perfusion pressure (CPP) in patients with severe traumatic brain injury (TBI).
Read the detailed description
Experience with rsO2 assessed by near infrared spectroscopy (NIRS) in patients with severe TBI is lacking. Reports about the usefulness of rSO2 are contradictory as regards its technical reliability and clinical value. Continuous time-domain analysis comparing rSO2, PbtO2 and CPP has never been carried out and the correlation among these variables remains largely unknown. A significant association between rSO2 and these clinically important variables would suggest that cerebral oximetry provides relevant data signifying that rSO2 might be a useful tool assessing cerebral oxygenation in selected patients with TBI.
- Conditions
- Brain Injuries
- Being tested
- transcranial oxygen saturation measurement (INVOS Somanetics 5100C)
- Keywords
- traumatic, brain injury, brain regional oxygen saturation (rSO2), brain tissue oxygenation (PbtO2), cerebral perfusion pressure (CPP)
- Medical subject headings
- Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcranial oxygen saturation measurement (INVOS Somanetics 5100C)Device
Also called INVOS Somanetics 5100C
rSO2 measurement
What is being measured
The primary outcome is the main question the study is designed to answer.
correlation between rSO2 and PbtO2
Measured: four months
Secondary outcomes (1)
correlation between rSO2 and CPP
Measured: four months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2008 (estimated)
- Study startJul 2008
- Primary completionApr 2009
- Study completionApr 2009
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 Brain InjuriesStudies 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
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospitales Universitarios Virgen del Rocío
- Sponsor type
- University, hospital or other
- Investigators
- Santiago R Leal-Noval, M.D., PhD, Principal investigator, Hospital Universitario "Virgen del Rocío", Seville, SpainAurelio Cayuela, M.D., PhD, Study chair, Hospital Universitario "Virgen del Rocío", Seville, SpainVictoria Arellano, M.D., PhD, Study chair, Hospital Universitario "Virgen del Rocío", Seville, SpainYael Corcia, M.D., Study chair, Hospital Universitario "Virgen del Rocío", Seville, SpainVicente Padilla, M.D., Study chair, Hospital Universitario "Virgen del Rocío", Seville, SpainClaudio Garcia-Alfaro, M.D., PhD, Study chair, Hospital Universitario "Virgen del Rocío", Seville, SpainAntonio Marín, M.D., PhD, Study chair, Hospital Universitario "Virgen del Rocío", Seville, SpainFrancisco Murillo, M.D., PhD, Study director, Hospital Universitario "Virgen del Rocío", Seville, Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00703495
- Sponsor's protocol ID
- PI 06/2008
- Status last verified
- Apr 2009
- First submitted
- 19 Jun 2008
- Last updated
- 6 Apr 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Leal-Noval SR, Cayuela A, Arellano-Orden V, Marin-Caballos A, Padilla V, Ferrandiz-Millon C, Corcia Y, Garcia-Alfaro C, Amaya-Villar R, Murillo-Cabezas F. Invasive and noninvasive assessment of cerebral oxygenation in patients with severe traumatic brain injury. Intensive Care Med. 2010 Aug;36(8):1309-17. doi: 10.1007/s00134-010-1920-7. Epub 2010 May 26.
PubMed 20502869
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Non- Invasive Regional Transcranial Oxygen Saturation (rSO2) by Comparison With Invasive Brain Tissue Oxygenation (PbtO 2) Measurement in Patients With Severe Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT00703495
- Acronym / sponsor ID
- PI 06/2008
- Conditions
- Brain Injuries
- Keywords
- traumatic, brain injury, brain regional oxygen saturation (rSO2), brain tissue oxygenation (PbtO2), cerebral perfusion pressure (CPP)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Hospitales Universitarios Virgen del RocíoUniversity, hospital or other
- Study start
- Jul 2008
- Primary completion
- Apr 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 23 Jun 2008 (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 investigate the relationship among regional transcranial oxygen saturation (rSO2), brain tissue oxygen pressure (PbtO2) and cerebral perfusion pressure (CPP) in patients with severe traumatic brain injury (TBI).
Detailed description
Experience with rsO2 assessed by near infrared spectroscopy (NIRS) in patients with severe TBI is lacking. Reports about the usefulness of rSO2 are contradictory as regards its technical reliability and clinical value. Continuous time-domain analysis comparing rSO2, PbtO2 and CPP has never been carried out and the correlation among these variables remains largely unknown. A significant association between rSO2 and these clinically important variables would suggest that cerebral oximetry provides relevant data signifying that rSO2 might be a useful tool assessing cerebral oxygenation in selected patients with TBI.
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Stable patients with severe traumatic brain injury (Glasgow Coma Scale < 9) monitored through intracranial pressure (ICP) and brain tissue partial pressure of oxygen (PbtO2) probe, inserted for indications other than inclusion in this study
Key inclusion criteria (3 listed)
- Severe Traumatic Brain Injury (Glasgow Coma Scale < 9)
- Having an intraparenchymal cerebral ICP/PbtO2 catheter previously inserted.
- Expected length of ICU stay > 1 days
Key exclusion criteria (4 listed)
- Patient's relatives refusal to patient's inclusion in the study
- Patients necessitating ongoing resuscitation
- End-stage in which death is imminent
- Deficient signal of rSO2 impeding its proper valuation
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 |
|---|---|---|
| transcranial oxygen saturation measurement (INVOS Somanetics 5100C)Also: INVOS Somanetics 5100CrSO2 measurement | Device | – |
Primary outcome
correlation between rSO2 and PbtO2
Time frame: four months
1 secondary outcome
correlation between rSO2 and CPP
Time frame: four months
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 6 Apr 2009.
- Derived from this study: PubMed 20502869Leal-Noval SR, Cayuela A, Arellano-Orden V, Marin-Caballos A, Padilla V, Ferrandiz-Millon C, Corcia Y, Garcia-Alfaro C, Amaya-Villar R, Murillo-Cabezas F. Invasive and noninvasive assessment of cerebral oxygenation in patients with severe traumatic brain injury. Intensive Care Med. 2010 Aug;36(8):1309-17. doi: 10.1007/s00134-010-1920-7. Epub 2010 May 26.
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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.
Santiago R Leal-Noval, M.D., PhD principal investigator
Hospital Universitario "Virgen del Rocío", Seville, Spain
Aurelio Cayuela, M.D., PhD study chair
Hospital Universitario "Virgen del Rocío", Seville, Spain
Victoria Arellano, M.D., PhD study chair
Hospital Universitario "Virgen del Rocío", Seville, Spain
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 Brain Injuries, run by Hospitales Universitarios Virgen del Rocío at 1 site in Spain.
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 4 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 6 Apr 2009. 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 Spain. 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?
correlation between rSO2 and PbtO2 (time frame: four months). 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 NCT00703495, 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 6 Apr 2009.