NIRS and Anesthesiology

July 28, 2023 updated by: Ars Gor Dr Oguzhan Gulgen, Trakya University

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.

Study Overview

Status

Active, not recruiting

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

Observational

Enrollment (Estimated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Edirne, Turkey
        • Trakya University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

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.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2022

Primary Completion (Estimated)

January 1, 2025

Study Completion (Estimated)

February 1, 2025

Study Registration Dates

First Submitted

July 28, 2023

First Submitted That Met QC Criteria

July 28, 2023

First Posted (Actual)

August 7, 2023

Study Record Updates

Last Update Posted (Actual)

August 7, 2023

Last Update Submitted That Met QC Criteria

July 28, 2023

Last Verified

July 1, 2023

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

No

Studies a U.S. FDA-regulated device product

No

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.

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