Can Optic Nerve Sheath Diameter Measurement Predict Negative Neurological Outcome ?

December 18, 2015 updated by: Ekrem Musalar, Emergency Medicine Association of Turkey

Can Bedside Ultrasonographic Measurements of Optic Nerve Sheath Diameter Following the Return of Spontaneous Circulation Predict Negative Neurological Outcome in Out of Hospital Cardiac Arrest Patients?

This study is designed as a multicenter, prospective, cohort clinical study. The out of hospital cardiac arrest (OHCA) patients presenting to the adult emergency departments of the participating hospitals will render the study population. The non-traumatic, non-intracranial event related OHCA patients in whom the return of spontaneous circulation (ROSC) is achieved will render the sampling group.

The primary aim of this study is to evaluate the relationship of bedside ultrasound (USG) measurements of Optic Nerve Sheath Diameter (ONSD) following the ROSC after Cardiopulmonary resuscitation (CPR) for OHCA patients, with early (3rd day) neurological evaluation and 30 days survival rate, proposing that increased ONSD may be related to negative neurological outcomes. Considering a relationship is found, the secondary goals of the study are established as, identifying a cut-off value for ONSD related to negative neurological outcome and the optimal time to measure ONSD.

The sampling size with a power of 95% is calculated to be 203 patients. The patients whose available next of kin has given consent will be admitted to the study.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Introduction:

Current medical literature reveals that the life expectancy after cardiopulmonary resuscitation (CPR) for out of hospital cardiac arrest (OHCA) is 6.7-9.6%.1,2 The hypoxic process, also referred to as post-resuscitation encephalopathy (PRE), is a major factor affecting the neurological outcome following return of spontaneous circulation (ROSC).3 Many studies, aiming the early prediction of the neurological outcome via vital signs, scoring systems, various biochemical markers and imaging techniques exist in literature.1-8 Optic nerve is a part of central nervous system and its posterior part is covered with dura mater. Studies have found that, elevations in intracranial pressure (ICP) resulted in elevated subarachnoid fluid pressure, leading to increased optic nerve sheath diameter (ONSD).9 Bedside USG measurements of ONSD are reported to be utilizable for evaluation of ICP.9,10

Aim of the study:

The primary aim of this study is to evaluate the relationship of bedside USG measurements of ONSD following the ROSC after CPR for OHCA patients, with early (3rd day) neurological evaluation and 30 days survival rate, proposing that increased ONSD may be related to negative neurological outcomes. Considering a relationship is found, the secondary goals of the study are established as, identifying a cut-off value for ONSD related to negative neurological outcome and the optimal time to measure ONSD.

Material and Methods:

This study is designed as a multicenter, prospective, cohort clinical study. The Utstein Templates for Resuscitation Registries are used for OHCA records.11 The associate researchers are demanded to have an experience of at least 5 years in USG use and be certified by the Emergency Medicine Association of Turkey (EMAT) for participating and/or being a faculty in the Emergency USG courses on ONSD evaluation, by the EMAT USG study group (EMATUS), which organizes planned USG courses for Emergency Physicians. A one-day education to standardize the researchers of the study, with theoretical and implementation sections are planned to be held by the authors of the study, regarding the methodology of the study and standardization of the USG techniques for ONSD measurements. In the implementation section, the researchers will perform ONSD measurements with ocular USG on healthy volunteers and the reliability among performers will be measured with Interclass Correlation test.

This study will be performed in the adult emergency departments of the participating hospitals, after the ethics committee approval. The OHCA patients presenting to the adult emergency departments of the participating hospitals will render the study population. The non-traumatic, non-intracranial event related OHCA patients in whom the ROSC is achieved will render the sampling group. The sampling size with a power of 95% is calculated to be 203 patients. The patients whose available next of kin has given consent will be admitted to the study.

All patients will receive standardized advanced cardiac life support (ACLS) measures in line with the most recent American Heart Association (AHA) guidelines by emergency department teams, uncommitted to the study. Following the ROSC, a time period of 20 minutes is determined in order to appropriate tissue perfusion to be stated, with a systolic blood pressure ≥90 mmHg or mean arterial pressure ≥65 mmHg and peripheral capillary saturation ≥94%.14 ONSD measurements will be performed in patients who had uninterrupted ROSC for 20 minutes with bedside USG and the time between the achievement of ROSC and the measurement will be recorded. The routine care plan of the patients will not be manipulated. In case the clinician decides that a cranial computed tomography (CT) is indicated according to routine practices and current guidelines, a copy of the CT images will be taken to investigate the presence of an intracranial mass leading to increased ICP.

The neurologic evaluation of the patients in the study group will be performed in three steps. Primary neurological evaluation will be performed following the achievement of appropriate tissue perfusion after ROSC, prior to any sedative or paralyzing drug application. This step is about identifying and recording the alertness, presence of activity, and the level of motor response, brain stem reflexes and myoclonic status epilepticus. The second neurological evaluation will take place after the 72nd hour following the ROSC. The alertness, presence of spontaneous motor activity, and the level of motor response, brain stem reflexes and myoclonic status epilepticus will also be identified and recorded in the second step, as well. The third evaluation will be the evaluation of neurological final outcome at 30th day or hospital discharge, utilizing the Modified Rankin Scale (MRS).

Statistical Package for the Social Sciences 22.0 for Windows will be used for statistical analysis. Descriptive statistical values will be presented as quantity and percentiles for categorical variables and as mean and standard deviation for numerical variables. Comparisons of numerical variables between two independent groups will be performed by Student-t Test if normal distribution is obtained and by Mann-Whitney U test if it is not obtained. The differences between the mean values of categorical variables of two independent groups will be tested with Chi-Square analysis. The relationships between the numerical variables will be reviewed with Pearson Correlation analysis under parametric test conditions, and Spearman Correlation Analysis under non-parametric test conditions. The appropriateness of four separately measures ONSD values will be evaluated with concordance correlation coefficient measurement. The cut-off value will be determined with Receiver Operating Characteristics Curve Analysis. The statistical alpha significance level will be accepted as p<0.05.

Study Type

Observational

Enrollment (Anticipated)

203

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
      • Adana, Turkey
        • Recruiting
        • Başkent University
        • Contact:
      • Ankara, Turkey
      • Ankara, Turkey
      • Antalya, Turkey
        • Recruiting
        • Akdeniz University Hospital
        • Contact:
      • Antalya, Turkey
      • Denizli, Turkey
      • Erzurum, Turkey
        • Recruiting
        • Erzurum Education and Research Hospital
        • Contact:
      • Eskisehir, Turkey
        • Recruiting
        • Eskisehir Osmangazi University
        • Contact:
      • Eskişehir, Turkey
        • Recruiting
        • Yunus Emre State Hospital
        • Contact:
      • Istanbul, Turkey
      • Istanbul, Turkey
      • Istanbul, Turkey
        • Recruiting
        • Istanbul Haseki Education and Research Hospital
        • Contact:
      • Istanbul, Turkey
        • Recruiting
        • Istanbul Sıslı Hamidiye Etfal Education and Research Hospital
        • Contact:
      • Izmır, Turkey
      • Izmır, Turkey
      • Izmır, Turkey
        • Recruiting
        • Izmır Tepecik Education and Research Hospital
        • Contact:
      • Kocaeli, Turkey
      • Nevşehir, Turkey
      • İzmir, Turkey

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

Probability Sample

Study Population

The non-traumatic, non-intracranial event related OHCA patients in whom the ROSC is achieved will render the sampling group

Description

Inclusion Criteria:

1-Out-hospital cardiac arrest

Exclusion Criteria:

  1. In-hospital cardiac arrest
  2. Unstable patients requiring rapid intervention (i.e. emergent surgery, percutaneous coronary intervention)
  3. Age <18
  4. Concomitant trauma
  5. Pregnancy
  6. Any event known to increase ONSD without raised ICP (optic neuritis, arachnoid cysts of optic nerve, optic nerve trauma, anterior orbital mass, cavernous sinus mass)
  7. Any event known to increase ONSD with raised ICP [previously diagnosed intracranial space occupying lesion or tumor, pseudotumor cerebri, conditions causing decreased Cerebrospinal fluid (CSF) reabsorption (venous sinus thrombosis, inflammation, meningitis, subarachnoid hemorrhage)
  8. Conditions causing increased production CSF (tumors), ventricular obstructions, cerebral edema, craniosynostosis
  9. Anatomical eye malformations preventing the USG examination
  10. Previously diagnosed malignity, glaucoma, multiple sclerosis, previously diagnosed terminal stage liver and renal disease,
  11. Cardiac arrest secondary to trauma and refusing to give consent to participate

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Modified Rankin Scale (MRS).
Time Frame: 30 day after ROSC

0-No symptoms.

  1. No significant disability. Able to carry out all usual activities, despite some symptoms.
  2. Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.
  3. Moderate disability. Requires some help, but able to walk unassisted.
  4. Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.
  5. Severe disability. Requires constant nursing care and attention, bedridden, incontinent.
  6. Dead.
30 day after ROSC

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neurological Examination
Time Frame: 72 hours after ROSC
This step is about identifying and recording the alertness, presence of activity, and the level of motor response, brain stem reflexes and myoclonic status epilepticus.
72 hours after ROSC

Collaborators and Investigators

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

Sponsor

Emergency Medicine Association of Turkey

Investigators

  • Study Chair: Aslıhan Yürüktümen Ünal, Ass. Prof., Depertment Of Emergency Medicine, Akdeniz University, Antalya
  • Study Chair: Erkan Göksu, Ass. Prof., Depertment Of Emergency Medicine, Akdeniz University, Antalya
  • Study Chair: Faruk Güngör, MD, Depertment Of Emergency Medicine, Antalya Education and Research Hospital, Antalya
  • Study Chair: Betül Günalp, Ass. Prof, Depertment Of Emergency Medicine, Başkent University, Adana
  • Study Chair: Alten Oskay, MD, Depertment Of Emergency Medicine, Denizli State Hospital, Denizli
  • Study Chair: Mert Özen, MD, Depertment Of Emergency Medicine, Denizli State Hospital, Denizli
  • Study Chair: Başak Bayram, Assist. Prof, Depertment Of Emergency Medicine, Dokuz Eylul University, İzmir
  • Study Chair: Funda Karbek Akarca, Assist. Prof, Depertment Of Emergency Medicine, Ege University, İzmir
  • Study Chair: İlhan Uz, MD, Depertment Of Emergency Medicine, Ege University, İzmir
  • Study Chair: Nurdan Ergün Acar, Ass. Prof, Depertment Of Emergency Medicine, Eskisehir Osmangazi University, Eskisehir
  • Study Chair: Mustafa E. Çanakçı, Resident, Depertment Of Emergency Medicine, Eskisehir Osmangazi University, Eskisehir
  • Study Chair: Bülent Erbil, Ass. Prof., Depertment Of Emergency Medicine, Hacettepe University, Ankara
  • Study Chair: Mehmet A. Karaca, Ass. Prof., Depertment Of Emergency Medicine, Hacettepe University, Ankara
  • Study Chair: Özgür Dikme, MD, Depertment Of Emergency Medicine, Istanbul Education and Research Hospital, Istanbul
  • Study Chair: Adnan Yamanoglu, MD, Depertment Of Emergency Medicine, Istanbul Haseki Education and Research Hospital, Istanbul
  • Study Chair: Özgür Cevrim, MD, Depertment Of Emergency Medicine, Istanbul Sıslı Hamidiye Etfal Education and Research Hospital, Istanbul
  • Study Chair: Cem Ertan, Ass. Prof., Depertment Of Emergency Medicine, Izmır University, İzmir
  • Study Chair: Tanzer Korkmaz, Assist. Prof, Depertment Of Emergency Medicine, Izmır University, İzmir
  • Study Chair: Murat Yeşilaras, MD, Depertment Of Emergency Medicine, Izmır Tepecik Education and Research Hospital, Izmir
  • Study Chair: Turgay Y. Kılıç, MD, Depertment Of Emergency Medicine, Izmır Tepecik Education and Research Hospital, Izmir
  • Study Chair: Mehmet A. Aslaner, MD, Depertment Of Emergency Medicine, Nevşehir State Hospital, Nevşehir
  • Study Chair: Salih Ekinci, MD, Depertment Of Emergency Medicine, Koc University, İstanbul
  • Study Chair: Onur Karakayalı, MD, Depertment Of Emergency Medicine, Kocaeli Derince Education and Research Hospital, Kocaeli
  • Study Chair: Ali Batur, MD, Depertment Of Emergency Medicine, Erzurum Education and Research Hospital, Erzurum
  • Study Chair: Volkan Arslan, MD, Depertment Of Emergency Medicine, Ankara Education and Research Hospital, Ankara
  • Study Chair: Davut Kaplan, MD, Depertment Of Emergency Medicine, Yunus Emre State Hospital, Eskişehir

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

Helpful Links

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

December 1, 2015

Primary Completion (Anticipated)

February 1, 2017

Study Completion (Anticipated)

March 1, 2017

Study Registration Dates

First Submitted

December 15, 2015

First Submitted That Met QC Criteria

December 18, 2015

First Posted (Estimate)

December 22, 2015

Study Record Updates

Last Update Posted (Estimate)

December 22, 2015

Last Update Submitted That Met QC Criteria

December 18, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TATDUS-0001

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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