Effectiveness of NIRS (Near-Infrared Spectroscopy) at Acute Ischemic Stroke Patients

Ischemic Stroke Clinical Trial

Official title: Effectiveness of NIRS (Near-Infrared Spectroscopy) in Indicating Cerebral Oxygenation at Acute Ischemic Stroke Patients Undergoing Intravenous Thrombolytic Therapy and / or Endovascular Thrombectomy

Status Recruiting

Clinical Trial Summary

Near-infrared spectroscopy (NIRS) is a non-invasive technology that continuously monitors regional tissue oxygenation (tissue saturation with oxygen). NIRS is used to evaluate the oxygen saturation of the brain and other tissues (such as muscle, liver, lung). NIRS is a non-invasive, simple, bedside method that can be used safely in stroke patients, as it is a method that can be performed at the bedside and does not affect the treatment process. The NIRS, which we will use in our study, continuously measures with the help of two electrodes affixed to the forehead area, right and left.

There are previously created scales and scales based on neurological examination in the follow-up of patients with acute ischemic stroke. The main ones are the Glasgow Coma Scale (GCS), which is used without evaluating the patient's consciousness; It is the National Institutes of Health Stroke Scale (NIHSS), which is used to evaluate the severity of ischemic stroke, its suitability for treatment and treatment response, and the Modified Rankin Scale (mRS), which is used to evaluate the daily activity ability of individuals. However, since these cannot predict the patient's response to treatment and complications that will develop early, and there are no objective parameters, there is a need for methods that require objective monitoring of the patients.

Acute ischemic stroke patients who received intravenous thrombolytic therapy with NIRS and / or who underwent endovascular thrombectomy are monitored for 24 hours and the data obtained from this method are compared with the vital findings, GCS, NIHSS, mRS, which are traditionally used in the follow-up of these patients. Thus, it was aimed to evaluate the utility of this method in evaluating the treatment efficacy and prognosis of patients compared to traditional methods in acute ischemic stroke patients.

Clinical Trial Description

Patients over the age of 18 who applied to Ege University Hospital Emergency Service with acute ischemic stroke and who were planned and applied intravenous thrombolytic and / or endovascular thrombectomy by the Neurology Specialist will be included in the study. Participants and / or their guardians will be informed about the study by the researcher and a written informed consent form will be obtained from those who agree to participate in the study. For those who meet the exclusion criteria from the study, the reason for exclusion will be recorded and excluded from the study. The patients included in the study will not be intervened in the diagnosis and treatment processes planned in the emergency department.

Two electrodes will be attached to the forehead area and connected to the Near Infrared Spectroscopy device after the consent of the patients who apply to Ege University Hospital Emergency Service with acute ischemic stroke and who are planned intravenous thrombolytic and / or endovascular thrombectomy treatment or treatments, and / or their caregivers.

The subjects participating in the study will be followed up during their 24-hour period in Ege University Medical Faculty Hospital Emergency Service patient care areas and Ege University Medical Faculty Hospital Neurology Intensive Care Unit. If the cases are transferred to another hospital, the follow-up of the cases will be terminated and they will be excluded from the study. The age, gender, application methods and risk factors of the subjects participating in the study will be recorded on the case report form.

In routine monitoring, blood pressure, pulse, blood oxygenation 0., 15., 30., 45., 60., 75., 90., 105., 120., 150., 180., 210., 240., 270., 300., 330., 360. minutes and at 7, 8, 9, 10, 11, 12, 14, 16, 18, 24 hours will be recorded in the report form . The time of onset of the findings in the anamnesis taken by the primary physician of the patient, the time of the patient's presentation, the time of the radiological imaging planned by the patient's primary physician, and the starting time of the treatment will be recorded in the case report form. Intravenous thrombolytic and / or endovascular thrombectomy treatment or treatments planned and applied to the patient within 24 hours will be recorded together with their timings. In addition, the transfer time of the case to the Intensive Care Unit and / or the time of transfer to the Interventional Radiology Unit and the duration of stay in the emergency department in patients who will undergo Endovascular Thrombectomy will be recorded in the case report form. Blood oxygenation of the cases is routinely performed with pulse oximetry, which has the same working principle as NIRS, and will be recorded in the case report form. In this way, NIRS measurements can be compared with systemic ischemia, which may affect NIRS measurements.

GCS, NIHSS 0., 15., 30., 45., 60., 75., 90., 105., 120., 150., 180., 210., 240., 270 , 300., 330., 360. minutes and at the 7th, 8th, 9th, 10th, 11th, 12th, 14th, 16th, 18th, 24th hours will be recorded in the report form.. MRS in the neurological examination performed by the primary physician of the patient will be recorded in the case report form at the time of application and at the time of end. The ASPECT scoring system, which is used to evaluate the affected brain region and brain region in the imaging performed to the cases, will be recorded in the case report form. In addition, right / left rSO2 and IHrSO2 0., 15., 30., 45., 60., 75., 90., 105., 120., 150., 180., 210., 240., 270., 300., 330., 360. Minutes and 7., 8., 9., 10., 11., 12., 14., 16., 18., 24. Hours will be recorded in the report form. All additional procedures that will affect NIRS measurements (resuscitation, sedation, interventional procedures) and developing complications will be recorded on the case report form within the 24-hour follow-up period.

Statistical analysis of the registered research data will be made. Further analysis will be determined according to whether the data show normal distribution or not, and the significance of the difference between the data will be evaluated in the opinion of the biostatistics expert. ;

Related Conditions & MeSH terms

• Cerebral Infarction
• Ischemia
• Ischemic Stroke
• Stroke

• NCT number: NCT04904172
• Study type: Observational [Patient Registry]
• Source: Ege University
• Contact: Emre Ersegün Günay, MD
• Phone: +90 505 155 99 95
• Email: ersegun@windowslive.com
• Status: Recruiting
• Start date: November 1, 2020
• Completion date: May 2023