Cognitive DysfunctionNCT03093311
Near Infrared Spectroscopy for Detection of Cerebral Desaturation After Positioning for Neurosurgical Procedures
A study testing NIRS based protocol in people with Cognitive Dysfunction and Patient Positioning, run by University Hospital Hradec Kralove at 1 site in Czechia.
Trial summary
The occurrence of postoperative cognitive dysfunction (POCD) might be related to intraoperative cerebral desaturation. Positioning for neurosurgical procedures are associated with head rotation, elevation, flexion or extention that may affect blood brain inflow and outflow. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cognitive Dysfunction, Patient Positioning
- What is being tested?
- NIRS based protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Apr 2017to 30 Jun 2019
- Phase
- Interventional
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Glasgow Coma Scale 15, American Society of Anaesthesiologists (ASA) Physical Status Classification System Grade I-III, patient positioning with elevation, rotation, flexion or extention of head
Who cannot join
- Inability to past the Addenbrooke test, postoperative ventilation, awake phase during surgery, lung disease with retention of carbon dioxide, neurological disease before surgery (aphasia, paresis, blindness, deafness)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Near Infrared Spectroscopy for Detection of Cerebral Desaturation After Positioning for Neurosurgical Procedure
The occurrence of postoperative cognitive dysfunction (POCD) might be related to intraoperative cerebral desaturation. Positioning for neurosurgical procedures are associated with head rotation, elevation, flexion or extention that may affect blood brain inflow and outflow. Anatomical variations of Willis circle could affect the cerebral blood flow in extreme head position with the development of cerebral ischemia or functional changes of brain. Investigators suppose that detection of cerebral tissue desaturation and its prompt correction could modify the occurence of POCD after these procedures.
Read the detailed description
Standardized anesthesia and perioperative care will be provided to all patiens with positioning for neurosurgical or spinal procedures, where the head is elevated, extended. flected or rotated. In group A before the start of general anesthesia, the baseline level of cerebral tissue oxygenation (rScO2) will be measured using the near-infrared spectroscopy NIRS (Invivo Medtronic) . Continuous measurement of rScO2 will be used for detection of cerebral tissue desaturation. Each desaturation episode will be managed according to a standardized protocol - correction of extreme head position will be followed by optimalisation of mean arterial pressure (MAP), arterial hemoglobin oxygen saturation, end tidal carbon dioxide concentration and a level of hemoglobine concentration. In group B neither measurement of rScO2 nor interventions are provided. Cognitive dysfunction will be assessed by Adenbrooke test before operation and on the fifth postoperative day.
- Conditions
- Cognitive Dysfunction, Patient Positioning
- Being tested
- NIRS based protocol
- Keywords
- Near-Infrared Spectroscopy, Neurosurgical Procedures, Cognitive Dysfunction
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NIRS based protocolOther
Each desaturation episode will be managed according to a standardized protocol - correction of extreme head position will be followed by optimisation of mean arterial pressure (MAP), arterial hemoglobin oxygen saturation, end tidal carbon dioxide concentration and a level of hemoglobine concentration.
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | Brain tissue oxygenation is measured by NIRS. In time of desaturation the interventions according to NIRS based protocol start. Receives: Other: NIRS based protocol |
| Arm B | No intervention | Brain tissue oxygenation is not measured. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of incidence of postoperative cognitive dysfunction (POCD)
Addenbrooke test
Measured: 1 day before operation and the fifth´day
Secondary outcomes (5)
Operative position of patient
In grades from neutral position
Measured: first 30 minutes
Age of patients
18 to 79
Measured: the first 5 minutes
Level of exhaled carbon dioxide
In torr
Measured: every 5 minutes
Type and duration of procedure
In minutes
Measured: 10 minutes after procedure
Dose of catecholamines
In microgramms per kg per minute
Measured: 5 minutes after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2017
- Study start1 Apr 2017
- Primary completion31 Dec 2018
- Study completion30 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive DysfunctionStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Hradec Kralove
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dostalova Vlasta, MD, PhD, University Hospital Hradec Kralove
- Investigators
- Vlasta Dostalova, MD, PhD, Principal investigator, University Hospital Hradec Kralove
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03093311
- Sponsor's protocol ID
- UHHradecKralove 2017/01
- Status last verified
- Sep 2019
- First submitted
- 14 Mar 2017
- Last updated
- 1 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Near Infrared Spectroscopy for Detection of Cerebral Desaturation After Positioning for Neurosurgical Procedure
- ClinicalTrials.gov ID
- NCT03093311
- Acronym / sponsor ID
- UHHradecKralove 2017/01
- Conditions
- Cognitive Dysfunction, Patient Positioning
- Keywords
- Near-Infrared Spectroscopy, Neurosurgical Procedures, Cognitive Dysfunction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University Hospital Hradec KraloveUniversity, hospital or other
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 28 Mar 2017 (actual)
- 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 occurrence of postoperative cognitive dysfunction (POCD) might be related to intraoperative cerebral desaturation. Positioning for neurosurgical procedures are associated with head rotation, elevation, flexion or extention that may affect blood brain inflow and outflow. Anatomical variations of Willis circle could affect the cerebral blood flow in extreme head position with the development of cerebral ischemia or functional changes of brain. Investigators suppose that detection of cerebral tissue desaturation and its prompt correction could modify the occurence of POCD after these procedures.
Detailed description
Standardized anesthesia and perioperative care will be provided to all patiens with positioning for neurosurgical or spinal procedures, where the head is elevated, extended. flected or rotated. In group A before the start of general anesthesia, the baseline level of cerebral tissue oxygenation (rScO2) will be measured using the near-infrared spectroscopy NIRS (Invivo Medtronic) . Continuous measurement of rScO2 will be used for detection of cerebral tissue desaturation. Each desaturation episode will be managed according to a standardized protocol - correction of extreme head position will be followed by optimalisation of mean arterial pressure (MAP), arterial hemoglobin oxygen saturation, end tidal carbon dioxide concentration and a level of hemoglobine concentration. In group B neither measurement of rScO2 nor interventions are provided. Cognitive dysfunction will be assessed by Adenbrooke test before operation and on the fifth postoperative day.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Other: NIRS based protocolBrain tissue oxygenation is measured by NIRS. In time of desaturation the interventions according to NIRS based protocol start. |
| Arm B | No intervention | –Brain tissue oxygenation is not measured. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Glasgow Coma Scale 15, American Society of Anaesthesiologists (ASA) Physical Status Classification System Grade I-III, patient positioning with elevation, rotation, flexion or extention of head
Key exclusion criteria (1 listed)
- Inability to past the Addenbrooke test, postoperative ventilation, awake phase during surgery, lung disease with retention of carbon dioxide, neurological disease before surgery (aphasia, paresis, blindness, deafness)
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 |
|---|---|---|
| NIRS based protocolEach desaturation episode will be managed according to a standardized protocol - correction of extreme head position will be followed by optimisation of mean arterial pressure (MAP), arterial hemoglobin oxygen saturation, end tidal carbon dioxide concentration and a level of hemoglobine concentration. | Other | Arm A |
Primary outcome
Reduction of incidence of postoperative cognitive dysfunction (POCD)
Time frame: 1 day before operation and the fifth´day
Addenbrooke test
5 secondary outcomes
Operative position of patient
Time frame: first 30 minutes
Age of patients
Time frame: the first 5 minutes
Level of exhaled carbon dioxide
Time frame: every 5 minutes
Type and duration of procedure
Time frame: 10 minutes after procedure
Dose of catecholamines
Time frame: 5 minutes after procedure
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 1 Oct 2019.
- Individual participant dataSharing planned: No
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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.
Vlasta Dostalova, MD, PhD principal investigator
University Hospital Hradec Kralove
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NIRS based protocol in people with Cognitive Dysfunction and Patient Positioning, run by University Hospital Hradec Kralove at 1 site in Czechia.
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: finished, as of the sponsor's last update on 1 Oct 2019. 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 Czechia. 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?
Reduction of incidence of postoperative cognitive dysfunction (POCD) (time frame: 1 day before operation and the fifth´day). It is what the study was designed to measure, not a finding.
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 1 Oct 2019; AzTrials last refreshed its copy on 8 Nov 2026.