Cerebral Arterial DiseaseNCT00512447
Normal Values of Brain Oxygenation
An observational study of Cerebral Arterial Disease, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
New technology allows non-invasive monitoring of brain oxygenation (Near-Infrared-Spectroscopy). However, there are no large series of normal values in various adult age groups. We hypothesised that baseline values in patients breathing room air are lower in old patients than in younger subjects and that younger… Read more about this study
- Who is it for?
- Ages 25 to 95 years
- Conditions the study is for
- Cerebral Arterial Disease
- How many people
- 171 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jul 2007to 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 25 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing elective surgery
Who may be able to join
- Age between 25 and 95 years undergoing a elective surgical procedure
Who cannot join
- History of cerebral disease
- Dependence on supplemental oxygen
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Department of Anaesthesia, University Hospital Basel
Basel, Canton of Basel-City, 4031
About this study
Official title: Normal Values of Cerebral Oxygenation
New technology allows non-invasive monitoring of brain oxygenation (Near-Infrared-Spectroscopy). However, there are no large series of normal values in various adult age groups. We hypothesised that baseline values in patients breathing room air are lower in old patients than in younger subjects and that younger patients respond increase their brain oxygenation more in response to supplemental oxygen.
- Conditions
- Cerebral Arterial Disease
- Keywords
- Aging
- Medical subject headings
- Cerebral Arterial Diseases
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2007 (estimated)
- Study startJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral Arterial DiseaseStudies 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 only
- Time perspective
- Prospective
- Enrolment
- 171 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Investigators
- Luzius A Steiner, MD, PhD, Principal investigator, Department of Anaesthesia, University Hospital Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00512447
- Sponsor's protocol ID
- EK 62/07
- Status last verified
- Sep 2010
- First submitted
- 6 Aug 2007
- Last updated
- 14 Sep 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Normal Values of Cerebral Oxygenation
- ClinicalTrials.gov ID
- NCT00512447
- Acronym / sponsor ID
- EK 62/07
- Conditions
- Cerebral Arterial Disease
- Keywords
- Aging
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 171 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- Jul 2007
- First posted
- 7 Aug 2007 (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.
New technology allows non-invasive monitoring of brain oxygenation (Near-Infrared-Spectroscopy). However, there are no large series of normal values in various adult age groups. We hypothesised that baseline values in patients breathing room air are lower in old patients than in younger subjects and that younger patients respond increase their brain oxygenation more in response to supplemental oxygen.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 25 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing elective surgery
Key inclusion criteria (1 listed)
- Age between 25 and 95 years undergoing a elective surgical procedure
Key exclusion criteria (2 listed)
- History of cerebral disease
- Dependence on supplemental oxygen
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 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 14 Sep 2010.
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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.
Luzius A Steiner, MD, PhD principal investigator
Department of Anaesthesia, University Hospital Basel, Switzerland
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 Cerebral Arterial Disease, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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 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 14 Sep 2010. 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 Switzerland. 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.
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 14 Sep 2010.