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

March 22, 2022 updated by: Emre Ersegun Gunay, Ege University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

54

Contacts and Locations

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

Study Contact

Study Contact Backup

Study Locations

  • Turkey
    • Bornova
      • İzmir, Bornova, Turkey, 35100
        • Recruiting
        • Ege University, Department of Emergency Medicine
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Ayşe Güler, assoc. prof.
        • Sub-Investigator:
          • Celal Çınar, assoc. prof.
        • Sub-Investigator:
          • Asım Orujov, MD

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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.

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
Intervention / Treatment
Acute ischemic stroke who undergo intravenous thrombolytic and / or endovascular thrombectomy
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.
Device: Masimo O3 Regional Oximetry
wo 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 to have intravenous thrombolytic and / or endovascular thrombectomy treatment or treatments, and / or their caregivers.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Condition Determined by NIHSS
Time Frame: 24 hours or death or referral of patients to another hospital or another unit
Patient Clinically improved or unimproved determined by NIHSS
24 hours or death or referral of patients to another hospital or another unit
Clinical Condition Determined by GCS
Time Frame: 24 hours or death or referral of patients to another hospital or another unit
Patient Clinically improved or unimproved determined by GCS
24 hours or death or referral of patients to another hospital or another unit
rSO2 measurements
Time Frame: 24 hours or death or referral of patients to another hospital or another unit
Right / left rSO2 is the oxygen saturation of the right and left hemispheres of the brain measured with the help of electrodes. On the other hand, IHrsO2 is found by subtracting rSO2 at unaffected hemisphere of brain from the rSO2 at affected side of the brain from ischemia. In the studies carried out, a change of 4% in unilateral rSO2 and 2% in IhrSO2 is considered significant. In this study significant changes at rSO2 will be determined after statystical analysis
24 hours or death or referral of patients to another hospital or another unit

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood Pressure
Time Frame: 24 hours or death or referral of patients to another hospital or another unit
rSO2 measurements affected by change in blood pressure
24 hours or death or referral of patients to another hospital or another unit
Blood Oxygen Saturations
Time Frame: 24 hours or death or referral of patients to another hospital or another unit
rSO2 measurements affected by change in Oxygen Saturations
24 hours or death or referral of patients to another hospital or another unit
Drug interventions
Time Frame: 24 hours or death or referral of patients to another hospital or another unit
rSO2 measurements affected by change in Drug interventions
24 hours or death or referral of patients to another hospital or another unit
Change in MRS score
Time Frame: 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.
rSO2 measurements to decide MRS change
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.

Collaborators and Investigators

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

Sponsor

Ege University

Investigators

  • Study Director: Funda Karbek Akarca, assoc.prof., Ege University Department of Emergency Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

November 1, 2020

Primary Completion (Anticipated)

November 1, 2022

Study Completion (Anticipated)

May 1, 2023

Study Registration Dates

First Submitted

May 12, 2021

First Submitted That Met QC Criteria

May 22, 2021

First Posted (Actual)

May 27, 2021

Study Record Updates

Last Update Posted (Actual)

March 23, 2022

Last Update Submitted That Met QC Criteria

March 22, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22848

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

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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