- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05978310
NIRS and Anesthesiology
The Effect of Patient Position on Cerebral Regional Oxygen Saturation in Intracranial Surgeries
Study Overview
Status
Conditions
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 Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
-
-
-
Edirne, Turkey
- Trakya University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients who will undergo intracranial surgery
- Patients aged 25-75 years
- Patients in the ASA I-II-III risk group
Exclusion Criteria:
- Patients with a GCS below 15
- patients with heart failure, renal failure, liver failure
- patients with congenital neurological deficits
- patients who cannot be contacted
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
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 the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
NIRS values
Time Frame: October 1, 2022 /February 1, 2025
|
October 1, 2022 /February 1, 2025
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Trakya U/Anesthesiology
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on NIRS and Anesthesiology
-
University of DebrecenCompleted
-
Ottawa Hospital Research InstituteCanadian Institutes of Health Research (CIHR)RecruitingSurgery | AnesthesiologyCanada
-
Yonsei UniversityCompletedAnesthesiology TraineeKorea, Republic of
-
Sisli Hamidiye Etfal Training and Research HospitalCompletedPediatrics | Anesthesiology
-
Centre Hospitalier Universitaire de NīmesCompletedSatisfaction, Patient | Surgery | AnesthesiologyFrance
-
Centre Hospitalier Universitaire de NīmesCompletedSatisfaction, Patient | Surgery | AnesthesiologyFrance
-
Regina Elena Cancer InstituteUnknown
-
Cork University HospitalTerminated
-
Nanjing First Hospital, Nanjing Medical UniversityNot yet recruitingTraining | Ultrasound | Anesthesiology | Non-invasive | Residency | NeedleChina
-
General Hospital of Ningxia Medical UniversityCompletedAnesthesiology Management | AnesthesiologyChina