Regional Cerebral Oxygen Saturation During Head RotationNIRSNCT01760369
Study of the: Effect of Head Rotation in Prone Position on Regional Cerebral Oxygen Saturation.
An observational study of Regional Cerebral Oxygen Saturation During Head Rotation, run by Glostrup University Hospital, Copenhagen at 1 site in Denmark.
Trial summary
The purpose of this study is to determine whether head rotation in prone positon affects regional cerebral oxygenation (rSO2)in anesthetized patients undergoing lower back surgery. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Regional Cerebral Oxygen Saturation During Head Rotation
- How many people
- 52 participants
- Where
- 1 siteDenmark
- Study dates
- Oct 2012to Apr 2013
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing lowerback surgery under universal anesthesia at Glostrup Hospital, Copenhagen.
Who may be able to join
- Lower back surgery
- Age [18-80]
- ASA group I-III
- free and painless movement of the neck (including flexion, extension and rotation)
Who cannot join
- Pain during neck movement as mentioned under inclusion criteria.
- known history of cervical spine pathology or pathology of central nervous system including cerebrovascular disease
- any stenosis of the carotid vessels or known symptoms associated with such
- BMI > 35
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Observation Study of the: Effect of Head Rotation in Prone Position on Regional Cerebral Oxygen Saturation (rSO2) in Anesthetized Patients.
The purpose of this study is to determine whether head rotation in prone positon affects regional cerebral oxygenation (rSO2)in anesthetized patients undergoing lower back surgery.
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in regional cerebral oxygenation (rSO2)
Before, during and immediately after awaking from anesthesia
Measured: 1 day
Secondary outcomes (1)
Post anesthetic complications
During stay at the post anesthetic care unit. Any new neurological symptoms, pain from the neck, visual symptoms etc.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2013 (estimated)
- Study startOct 2012
- Primary completionApr 2013
- Study completionApr 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 Regional Cerebral Oxygen Saturation During Head RotationStudies 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
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Glostrup University Hospital, Copenhagen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Johnny Andersen, Glostrup University Hospital, Copenhagen
- Investigators
- Johnny DH Andersen, Doctor, Principal investigator, Doctor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01760369
- Sponsor's protocol ID
- NIRS-JDHA-12
- Acronym
- NIRS
- Status last verified
- Jan 2013
- First submitted
- 20 Dec 2012
- Last updated
- 14 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Andersen JD, Baake G, Wiis JT, Olsen KS. Effect of head rotation during surgery in the prone position on regional cerebral oxygen saturation: A prospective controlled study. Eur J Anaesthesiol. 2014 Feb;31(2):98-103. doi: 10.1097/EJA.0000000000000028.
PubMed 24335413
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observation Study of the: Effect of Head Rotation in Prone Position on Regional Cerebral Oxygen Saturation (rSO2) in Anesthetized Patients.
- ClinicalTrials.gov ID
- NCT01760369
- Acronym / sponsor ID
- NIRS / NIRS-JDHA-12
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Glostrup University Hospital, CopenhagenUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 4 Jan 2013 (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 head rotation in prone positon affects regional cerebral oxygenation (rSO2)in anesthetized patients undergoing lower back surgery.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing lowerback surgery under universal anesthesia at Glostrup Hospital, Copenhagen.
Key inclusion criteria (4 listed)
- Lower back surgery
- Age [18-80]
- ASA group I-III
- free and painless movement of the neck (including flexion, extension and rotation)
Key exclusion criteria (4 listed)
- Pain during neck movement as mentioned under inclusion criteria.
- known history of cervical spine pathology or pathology of central nervous system including cerebrovascular disease
- any stenosis of the carotid vessels or known symptoms associated with such
- BMI > 35
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
Change in regional cerebral oxygenation (rSO2)
Time frame: 1 day
Before, during and immediately after awaking from anesthesia
1 secondary outcome
Post anesthetic complications
Time frame: 1 day
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 Nov 2013.
- Derived from this study: PubMed 24335413Andersen JD, Baake G, Wiis JT, Olsen KS. Effect of head rotation during surgery in the prone position on regional cerebral oxygen saturation: A prospective controlled study. Eur J Anaesthesiol. 2014 Feb;31(2):98-103. doi: 10.1097/EJA.0000000000000028.
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.
Johnny DH Andersen, Doctor principal investigator
Doctor
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 Regional Cerebral Oxygen Saturation During Head Rotation, run by Glostrup University Hospital, Copenhagen at 1 site in Denmark.
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 4 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 14 Nov 2013. 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 Denmark. 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?
Change in regional cerebral oxygenation (rSO2) (time frame: 1 day). 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 NCT01760369, 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 14 Nov 2013.