NIRS and AnesthesiologyNCT05978310
NIRS and Anesthesiology
An observational study of NIRS and Anesthesiology, run by Trakya University at 1 site in Turkey (Türkiye).
Trial summary
Our aim in this study is to investigate the effects of the positions applied in Intracranial Surgery on Cerebral Oxygenation(with NIRS device) and to evaluate the superiority of the patient positions used to each other. Read more about this study
- Who is it for?
- Ages 25 to 75 years
- Conditions the study is for
- NIRS and Anesthesiology
- How many people
- 150 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2022to 1 Feb 2025
- 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 75 years
- All sexes
- Adult, Older adult
Study population: 150 patients in the ASA I-II-III risk group between the ages of 25-75 who will undergo intracranial surgery at Trakya University Medical Faculty Hospital will be included in the study.
Who may be able to join
- Patients who will undergo intracranial surgery
- Patients aged 25-75 years
- Patients in the ASA I-II-III risk group
Who cannot join
- Patients with a GCS below 15
- patients with heart failure, renal failure, liver failure
- patients with congenital neurological deficits
- patients who cannot be contacted
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Patient Position on Cerebral Regional Oxygen Saturation in Intracranial Surgeries
Our aim in this study is to investigate the effects of the positions applied in Intracranial Surgery on Cerebral Oxygenation(with NIRS device) and to evaluate the superiority of the patient positions used to each other.
Read the detailed description
One of the main goals during anesthesia practice is to provide adequate tissue oxygenation. For this purpose, many parameters such as ECG, blood pressure, blood gas, and urine monitoring are monitored. However, it is a serious deficiency that the brain, which is the most sensitive organ to ischemia, is not monitored in intracranial surgeries . Trying to keep the intraoperative blood gas parameters and cerebral blood flow at normal values in order to overcome this deficiency brings along serious problems in proportion to the frequency of the measurement interval. For this reason, evaluation of tissue oxygenation with the Near Infrared Spectroscopy (NIRS) method has come to the fore in recent years, and especially cerebral regional oxygen saturation (rSo2) follow-ups have begun to be performed more frequently. The values obtained by this method represent 75% venous, 20% arterial and 5% capillary compartment of the measurement area .
While deciding on the positions applied in intracranial surgery, it may be necessary to apply modifications by keeping the surgical application site in the foreground. The preferred patient position in the operation can help prevent complications and serious side effects. Although each position applied in intracranial operations has advantages and disadvantages, the surgeon should choose the most suitable position for the patient and pathology. The "park bench" position is widely used in posterior fossa operations and has replaced the sitting position for most neurosurgical procedures . However, since the advantages of the sitting position could not be obtained, this position was also changed and the modified Park bench position with 30 degrees upside tilt was used. This position can provide similar advantages with the sitting position and also reduces the risk of venous air embolism and hypotension . The modified sitting position for posterior fossa surgery versus the semi-sitting or "beach chair" position retains many of the advantages and provides a rapid trendelenburg in case of air embolism. The classical sitting position causes postural hypotension in approximately 1/3 of the patients and severe hypotension is seen in 2-5% of the patients. Excellent surgical intervention, drier area and less blood loss, reduced facial swelling are the advantages of the sitting position. However, the risk of venous air embolism and increased pneumocephalus should not be ignored.
In addition to the hemodynamic changes due to all these known positions, there is no follow-up of cerebral regional oxygen saturation (rSo2) monitoring depending on the position, which we could not detect in the literature. This monitoring can contribute to the optimal continuation of cerebral blood flow while deciding on the appropriate position of the patients. In this case, the postoperative mortality and morbidity of the patients can be reduced. In addition, intraoperative cerebral oxygenation monitoring is critical for predicting delirium in the postoperative period.
Our aim in this study is to investigate the effects of the positions applied in Intracranial Surgery on Cerebral Oxygenation and to evaluate the superiority of the patient positions used to each other.
- Conditions
- NIRS and Anesthesiology
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 |
|---|---|---|
| Group P | Patients operated in the prone position | |
| Group S | Patients operated in the supine position | |
| Group L | Patients operated in the lateral position |
What is being measured
The primary outcome is the main question the study is designed to answer.
NIRS values
Measured: October 1, 2022 /February 1, 2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2023
- Study start1 Oct 2022
- Primary completion1 Jan 2025 (estimated)
- Study completion1 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NIRS and AnesthesiologyStudies 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-control
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Trakya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ars Gor Dr Oguzhan Gulgen, Trakya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05978310
- Sponsor's protocol ID
- Trakya U/Anesthesiology
- Status last verified
- Jul 2023
- First submitted
- 28 Jul 2023
- Last updated
- 7 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Patient Position on Cerebral Regional Oxygen Saturation in Intracranial Surgeries
- ClinicalTrials.gov ID
- NCT05978310
- Acronym / sponsor ID
- Trakya U/Anesthesiology
- Conditions
- NIRS and Anesthesiology
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Trakya UniversityUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 1 Feb 2025 (estimated)
- First posted
- 7 Aug 2023 (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.
Our aim in this study is to investigate the effects of the positions applied in Intracranial Surgery on Cerebral Oxygenation(with NIRS device) and to evaluate the superiority of the patient positions used to each other.
Detailed description
One of the main goals during anesthesia practice is to provide adequate tissue oxygenation. For this purpose, many parameters such as ECG, blood pressure, blood gas, and urine monitoring are monitored. However, it is a serious deficiency that the brain, which is the most sensitive organ to ischemia, is not monitored in intracranial surgeries . Trying to keep the intraoperative blood gas parameters and cerebral blood flow at normal values in order to overcome this deficiency brings along serious problems in proportion to the frequency of the measurement interval. For this reason, evaluation of tissue oxygenation with the Near Infrared Spectroscopy (NIRS) method has come to the fore in recent years, and especially cerebral regional oxygen saturation (rSo2) follow-ups have begun to be performed more frequently. The values obtained by this method represent 75% venous, 20% arterial and 5% capillary compartment of the measurement area .
While deciding on the positions applied in intracranial surgery, it may be necessary to apply modifications by keeping the surgical application site in the foreground. The preferred patient position in the operation can help prevent complications and serious side effects. Although each position applied in intracranial operations has advantages and disadvantages, the surgeon should choose the most suitable position for the patient and pathology. The "park bench" position is widely used in posterior fossa operations and has replaced the sitting position for most neurosurgical procedures . However, since the advantages of the sitting position could not be obtained, this position was also changed and the modified Park bench position with 30 degrees upside tilt was used. This position can provide similar advantages with the sitting position and also reduces the risk of venous air embolism and hypotension . The modified sitting position for posterior fossa surgery versus the semi-sitting or "beach chair" position retains many of the advantages and provides a rapid trendelenburg in case of air embolism. The classical sitting position causes postural hypotension in approximately 1/3 of the patients and severe hypotension is seen in 2-5% of the patients. Excellent surgical intervention, drier area and less blood loss, reduced facial swelling are the advantages of the sitting position. However, the risk of venous air embolism and increased pneumocephalus should not be ignored.
In addition to the hemodynamic changes due to all these known positions, there is no follow-up of cerebral regional oxygen saturation (rSo2) monitoring depending on the position, which we could not detect in the literature. This monitoring can contribute to the optimal continuation of cerebral blood flow while deciding on the appropriate position of the patients. In this case, the postoperative mortality and morbidity of the patients can be reduced. In addition, intraoperative cerebral oxygenation monitoring is critical for predicting delirium in the postoperative period.
Our aim in this study is to investigate the effects of the positions applied in Intracranial Surgery on Cerebral Oxygenation and to evaluate the superiority of the patient positions used to each other.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group P | – | –Patients operated in the prone position |
| Group S | – | –Patients operated in the supine position |
| Group L | – | –Patients operated in the lateral position |
Who may qualify
- Ages
- 25 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- 150 patients in the ASA I-II-III risk group between the ages of 25-75 who will undergo intracranial surgery at Trakya University Medical Faculty Hospital will be included in the study.
Key inclusion criteria (3 listed)
- Patients who will undergo intracranial surgery
- Patients aged 25-75 years
- Patients in the ASA I-II-III risk group
Key exclusion criteria (4 listed)
- Patients with a GCS below 15
- patients with heart failure, renal failure, liver failure
- patients with congenital neurological deficits
- patients who cannot be contacted
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
NIRS values
Time frame: October 1, 2022 /February 1, 2025
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2023.
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.
The record lists no contact. Use the official record to reach the sponsor.
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 NIRS and Anesthesiology, run by Trakya University at 1 site in Turkey (Türkiye).
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 3 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: status not confirmed, as of the sponsor's last update on 7 Aug 2023. 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 Turkey (Türkiye). 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?
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?
NIRS values (time frame: October 1, 2022 /February 1, 2025). 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 7 Aug 2023; AzTrials last refreshed its copy on 1 Nov 2026.