Clinical trial NCT04904172: Effectiveness of NIRS (Near-Infrared Spectroscopy) at Acute Ischemic Stroke Patients
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ischemic Stroke
Keywords: Spectroscopy
Near-Infrared
Stroke
Lead sponsor: Ege University
Sponsor class: OTHER
First posted: 2021-05-27
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients over the age of 18 who applied to Ege University Hospital Emergency Service with acute ischemic stroke and were planned and applied intravenous thrombolytic and / or endovascular thrombectomy treatment or treatments by a Neurology Specialist

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* Being over the age of 18
* Patients with acute ischemic stroke who applied to Ege University Emergency Service and decided to undergo intravenous thrombolytic and / or endovascular thrombectomy treatment or treatments by a Neurology Specialist.

Exclusion Criteria:

* Under 18 years old
* Trauma
* Resuscitation applied
* Patients presenting with acute ischemic stroke clinic but not eligible for intravenous thrombolytic and / or endovascular thrombectomy treatment or treatment.
* Patients without written consent
* Patients who cannot undergo NIRS monitoring for any reason
* Patients with skin lesions,hematoma, mass etc. in the forehead (electrode placement site).
* Having a level of jaundice on the skin that can be seen by inspection.

Primary outcomes:
measure: Clinical Condition Determined by NIHSS
timeFrame: 24 hours or death or referral of patients to another hospital or another unit
measure: Clinical Condition Determined by GCS
timeFrame: 24 hours or death or referral of patients to another hospital or another unit
measure: rSO2 measurements
timeFrame: 24 hours or death or referral of patients to another hospital or another unit
Secondary outcomes:
measure: Blood Pressure
timeFrame: 24 hours or death or referral of patients to another hospital or another unit
measure: Blood Oxygen Saturations
timeFrame: 24 hours or death or referral of patients to another hospital or another unit
measure: Drug interventions
timeFrame: 24 hours or death or referral of patients to another hospital or another unit
measure: Change in MRS score
timeFrame: From date of thrombolysis or thrombectomy has been made until death or admitting to another unit other than Stroke ICU or discharge,whicever came first, assessed up to 90 days.
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Ege University, Department of Emergency Medicine
state: Bornova
Study officials:
affiliation: Ege University Department of Emergency Medicine
name: Funda Karbek Akarca, assoc.prof.
role: STUDY_DIRECTOR
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