AnaesthesiaNCT01971996
Measuring the Effect of External Pressure on the Regional Cerebral Oxygen Saturation Monitored by Near-infrared Spectroscopy(NIRS) Technology
An observational study of Anaesthesia, run by Glostrup University Hospital, Copenhagen at 1 site in Denmark.
Trial summary
During general anaesthesia, to ensure sufficient oxygen supply to the brain, the NIRS technology can be used. It consist of two sensors placed on the forehead, and measures the oxygen saturation of the tissue underneath the sensor. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anaesthesia
- How many people
- 60 participants
- Where
- 1 siteDenmark
- Study dates
- Nov 2013to May 2014
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing lumbar spine surgury, and are placed in the prone position
Who may be able to join
- Surgery in the lumbar spine, in the prone position, with the head in a proneview facemask
- Free and painless movement of the neck
Who cannot join
- Known cervical spine pathology.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
University of Copenhagen, Glostrup Hospital
Copenhagen, Glostrup, 2600
About this study
Official title: Measuring the Cerebral Oxygen Saturation With NIRS Sensor Placed on the Forehead of Patients in the Prone Position. How Does the External Pressure Affect the Measurement.
During general anaesthesia, to ensure sufficient oxygen supply to the brain, the NIRS technology can be used. It consist of two sensors placed on the forehead, and measures the oxygen saturation of the tissue underneath the sensor. For patients undergoing back surgery placed in the prone position, the NIRS measurement will be affected, because the weight of the head will produce a pressure on the sensors. We wish to investigate how much the measurement is affected. Furthermore we plan to lift the head to remove the pressure, and record the time needed for the measurements to return to baseline.
Read the detailed description
When placed in the prone position an external pressure is applied to the NIRS sensor. This pressure changes the amount of blood in the underlying tissue and thereby has an influence on the regional cerebral oxygen saturation measured. We wish to investigate to which extend this value is affected by the external pressure. Furthermore by lifting the head we want to investigate how long takes for the measurements to return to baseline (no pressure in the supine position).
Patients will receive written and oral information about the study, when seen by an anaesthesiologist prior to surgery. Before the anaesthesia one NIRS sensors is placed on the right side of the forehead, avoiding til frontal sinus, and one NIRA sensor is placed on the left musculus deltoideus. The patient is placed in the prone position with the head in af prone-view face mask. Measurements will start after 30 minutes with no change in infusion rate of anaesthetic and no inotropics administered. Registration of NIRS measurements will be done every 15 seconds, first five minutes without intervention, then five minutes with headlift, and last five minutes without interventions. Blood pressure, pulse, saturation, end-tidal carbon dioxide and temperature, will be recorded. Registration wil be om case report forms.
- Conditions
- Anaesthesia
- Keywords
- Near infrared Spectroscopy
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 |
|---|---|---|
| Lumbar spine surgical patients | Patients undergoing lumbar spine surgery in the prone position |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the regional cerebral oxygen saturation
Measured by Near Infrared Spectroscopy
Measured: 15 seconds
Secondary outcomes (1)
The duration before the steady state in the regional cerebral oxygen saturation is obtained after changing the head position.
Measured: 15 seconds
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2013 (estimated)
- Study startNov 2013
- Primary completionMay 2014
- Study completionMay 2014
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 AnaesthesiaStudies 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
- 60 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, M.D., Principal investigator, University of Copenhagen, Glostrup Hospital, DenmarkHanna Siegel, M.D., Principal investigator, University of Copenhagen, Glostrup Hospital, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01971996
- Sponsor's protocol ID
- H-4-2013-FSP
- Status last verified
- Jul 2014
- First submitted
- 24 Oct 2013
- Last updated
- 2 Jul 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Siegel H, Andersen JD, Nielsen RV, Lorentzen K, Olsen KS. Measuring regional cerebral oxygen saturation during surgery in the prone position. Eur J Anaesthesiol. 2016 Feb;33(2):154-5. doi: 10.1097/EJA.0000000000000289. No abstract available.
PubMed 26086290
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measuring the Cerebral Oxygen Saturation With NIRS Sensor Placed on the Forehead of Patients in the Prone Position. How Does the External Pressure Affect the Measurement.
- ClinicalTrials.gov ID
- NCT01971996
- Acronym / sponsor ID
- H-4-2013-FSP
- Conditions
- Anaesthesia
- Keywords
- Near infrared Spectroscopy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Glostrup University Hospital, CopenhagenUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 30 Oct 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.
During general anaesthesia, to ensure sufficient oxygen supply to the brain, the NIRS technology can be used. It consist of two sensors placed on the forehead, and measures the oxygen saturation of the tissue underneath the sensor. For patients undergoing back surgery placed in the prone position, the NIRS measurement will be affected, because the weight of the head will produce a pressure on the sensors. We wish to investigate how much the measurement is affected. Furthermore we plan to lift the head to remove the pressure, and record the time needed for the measurements to return to baseline.
Detailed description
When placed in the prone position an external pressure is applied to the NIRS sensor. This pressure changes the amount of blood in the underlying tissue and thereby has an influence on the regional cerebral oxygen saturation measured. We wish to investigate to which extend this value is affected by the external pressure. Furthermore by lifting the head we want to investigate how long takes for the measurements to return to baseline (no pressure in the supine position).
Patients will receive written and oral information about the study, when seen by an anaesthesiologist prior to surgery. Before the anaesthesia one NIRS sensors is placed on the right side of the forehead, avoiding til frontal sinus, and one NIRA sensor is placed on the left musculus deltoideus. The patient is placed in the prone position with the head in af prone-view face mask. Measurements will start after 30 minutes with no change in infusion rate of anaesthetic and no inotropics administered. Registration of NIRS measurements will be done every 15 seconds, first five minutes without intervention, then five minutes with headlift, and last five minutes without interventions. Blood pressure, pulse, saturation, end-tidal carbon dioxide and temperature, will be recorded. Registration wil be om case report forms.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lumbar spine surgical patients | – | –Patients undergoing lumbar spine surgery in the prone position |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing lumbar spine surgury, and are placed in the prone position
Key inclusion criteria (2 listed)
- Surgery in the lumbar spine, in the prone position, with the head in a proneview facemask
- Free and painless movement of the neck
Key exclusion criteria (1 listed)
- Known cervical spine pathology.
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 the regional cerebral oxygen saturation
Time frame: 15 seconds
Measured by Near Infrared Spectroscopy
1 secondary outcome
The duration before the steady state in the regional cerebral oxygen saturation is obtained after changing the head position.
Time frame: 15 seconds
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 2 Jul 2014.
- Derived from this study: PubMed 26086290Siegel H, Andersen JD, Nielsen RV, Lorentzen K, Olsen KS. Measuring regional cerebral oxygen saturation during surgery in the prone position. Eur J Anaesthesiol. 2016 Feb;33(2):154-5. doi: 10.1097/EJA.0000000000000289. No abstract available.
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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.
Johnny DH Andersen, M.D. principal investigator
University of Copenhagen, Glostrup Hospital, Denmark
Hanna Siegel, M.D. principal investigator
University of Copenhagen, Glostrup Hospital, Denmark
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 Anaesthesia, 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 2 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: finished, as of the sponsor's last update on 2 Jul 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 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 the regional cerebral oxygen saturation (time frame: 15 seconds). 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 NCT01971996, 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 2 Jul 2014.