Changes in Cerebral Oxygenation During Different Patient PositioningNCT01275898
Comparison of INVOS and FORE SIGHT Cerebral Oximeter
An observational study of Changes in Cerebral Oxygenation During Different Patient Positioning and Coparison of Two Cerebral Oximeters, run by Johannes Gutenberg University Mainz at 1 site in Germany.
Trial summary
Cerebral oxygenation can be monitored using near infrared spectroscopy. Different devices are available to assess cerebral oxygenation noninvasively. Beach chair position is assumed to influence cerebral oxygenation. Litte is known about the influence of prone position and head down position on cerebral oxygenation. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Changes in Cerebral Oxygenation During Different Patient Positioning, Coparison of Two Cerebral Oximeters
- How many people
- 35 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2010to 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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients scheduled for surgical intervention in beach chair position, prone position and head down position
Who may be able to join
- age >18 and <80 years written informed consent
Who cannot join
- cerebrovascular disease coronary heart disease severe organ failure hemoglobin < 10mg/dl injury of forehead pregnancy
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Klinik für Anaesthesiologie Universitätsmedizin Mainz
Mainz, 55131
Closhen, closhen@uni-mainz.de
About this study
Official title: Assessing Cerebral Oxygenation During Different Surgical Procedures - Comparison of INVOS and ForeSight Cerebral Oximeter
Cerebral oxygenation can be monitored using near infrared spectroscopy. Different devices are available to assess cerebral oxygenation noninvasively. Beach chair position is assumed to influence cerebral oxygenation. Litte is known about the influence of prone position and head down position on cerebral oxygenation. The investigators hypothesize that these positions influence cerebral oxygenation. Further the investigators presume that the two cerebral oximeters INVOS and ForeSight provide comparable oxygenation data.
- Conditions
- Changes in Cerebral Oxygenation During Different Patient Positioning, Coparison of Two Cerebral Oximeters
- Keywords
- NIRS, cerebral oxygenation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Beach chair | Patients scheduled for surgical procedure in beach chair position (Shoulder surgery) | |
| Sitting position | Patients scheduled for surgical procedure in sitting position (Neurosurgery) | |
| Head down position | Patients scheduled for surgical procedure in head down position (daVinci robotic surgery) | |
| Prone position | Patients scheduled for surgical procedure in prone position |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2011 (estimated)
- Study startApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Changes in Cerebral Oxygenation During Different Patient PositioningStudies 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
- Cohort
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johannes Gutenberg University Mainz
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01275898
- Sponsor's protocol ID
- CLS_001
- Status last verified
- Mar 2010
- First submitted
- 12 Jan 2011
- Last updated
- 5 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Schramm P, Tzanova I, Hagen F, Berres M, Closhen D, Pestel G, Engelhard K. Cerebral oxygen saturation and cardiac output during anaesthesia in sitting position for neurosurgical procedures: a prospective observational study. Br J Anaesth. 2016 Oct;117(4):482-488. doi: 10.1093/bja/aew250. Epub 2016 Oct 17.
PubMed 28077536Closhen D, Engelhard K, Dette F, Werner C, Schramm P. Changes in cerebral oxygen saturation following prone positioning for orthopaedic surgery under general anaesthesia: a prospective observational study. Eur J Anaesthesiol. 2015 Jun;32(6):381-6. doi: 10.1097/EJA.0000000000000259.
PubMed 25828385Closhen D, Treiber AH, Berres M, Sebastiani A, Werner C, Engelhard K, Schramm P. Robotic assisted prostatic surgery in the Trendelenburg position does not impair cerebral oxygenation measured using two different monitors: A clinical observational study. Eur J Anaesthesiol. 2014 Feb;31(2):104-9. doi: 10.1097/EJA.0000000000000000.
PubMed 24225725
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Cerebral Oxygenation During Different Surgical Procedures - Comparison of INVOS and ForeSight Cerebral Oximeter
- ClinicalTrials.gov ID
- NCT01275898
- Acronym / sponsor ID
- CLS_001
- Conditions
- Changes in Cerebral Oxygenation During Different Patient Positioning, Coparison of Two Cerebral Oximeters
- Keywords
- NIRS, cerebral oxygenation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Johannes Gutenberg University MainzUniversity, hospital or other
- Study start
- Apr 2010
- First posted
- 13 Jan 2011 (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.
Cerebral oxygenation can be monitored using near infrared spectroscopy. Different devices are available to assess cerebral oxygenation noninvasively. Beach chair position is assumed to influence cerebral oxygenation. Litte is known about the influence of prone position and head down position on cerebral oxygenation. The investigators hypothesize that these positions influence cerebral oxygenation. Further the investigators presume that the two cerebral oximeters INVOS and ForeSight provide comparable oxygenation data.
Study design
- Observational model
- Cohort
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Beach chair | – | –Patients scheduled for surgical procedure in beach chair position (Shoulder surgery) |
| Sitting position | – | –Patients scheduled for surgical procedure in sitting position (Neurosurgery) |
| Head down position | – | –Patients scheduled for surgical procedure in head down position (daVinci robotic surgery) |
| Prone position | – | –Patients scheduled for surgical procedure in prone position |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled for surgical intervention in beach chair position, prone position and head down position
Key inclusion criteria (1 listed)
- age >18 and <80 years written informed consent
Key exclusion criteria (1 listed)
- cerebrovascular disease coronary heart disease severe organ failure hemoglobin < 10mg/dl injury of forehead pregnancy
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
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2011.
- Derived from this study: PubMed 28077536Schramm P, Tzanova I, Hagen F, Berres M, Closhen D, Pestel G, Engelhard K. Cerebral oxygen saturation and cardiac output during anaesthesia in sitting position for neurosurgical procedures: a prospective observational study. Br J Anaesth. 2016 Oct;117(4):482-488. doi: 10.1093/bja/aew250. Epub 2016 Oct 17.
- Derived from this study: PubMed 25828385Closhen D, Engelhard K, Dette F, Werner C, Schramm P. Changes in cerebral oxygen saturation following prone positioning for orthopaedic surgery under general anaesthesia: a prospective observational study. Eur J Anaesthesiol. 2015 Jun;32(6):381-6. doi: 10.1097/EJA.0000000000000259.
- Derived from this study: PubMed 24225725Closhen D, Treiber AH, Berres M, Sebastiani A, Werner C, Engelhard K, Schramm P. Robotic assisted prostatic surgery in the Trendelenburg position does not impair cerebral oxygenation measured using two different monitors: A clinical observational study. Eur J Anaesthesiol. 2014 Feb;31(2):104-9. doi: 10.1097/EJA.0000000000000000.
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.
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 Changes in Cerebral Oxygenation During Different Patient Positioning and Coparison of Two Cerebral Oximeters, run by Johannes Gutenberg University Mainz at 1 site in Germany.
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 1 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: status not confirmed, as of the sponsor's last update on 5 Aug 2011. 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 Germany. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01275898, which also lists 3 linked publications.
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 5 Aug 2011.