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Can Optic Nerve Sheath Diameter Measurement Predict Negative Neurological Outcome ?

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02637258
Recruitment Status : Unknown
Verified December 2015 by Ekrem Musalar, Emergency Medicine Association of Turkey.
Recruitment status was:  Recruiting
First Posted : December 22, 2015
Last Update Posted : December 22, 2015
Sponsor:
Information provided by (Responsible Party):
Ekrem Musalar, Emergency Medicine Association of Turkey

Brief Summary:

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.


Condition or disease Intervention/treatment
Out of Hospital Cardiac Arrest Neurologic Symptoms Other: Ultrasonographic Measurements of Optic Nerve Sheath Diameter

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 203 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Month
Official Title: 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?
Study Start Date : December 2015
Estimated Primary Completion Date : February 2017
Estimated Study Completion Date : March 2017

Resource links provided by the National Library of Medicine



Intervention Details:
  • Other: Ultrasonographic Measurements of Optic Nerve Sheath Diameter
    Bedside Ultrasonographic Measurements of Optic Nerve Sheath Diameter


Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02637258


Contacts
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Contact: Ekrem Musalar, MD +905065742474 emusalar@kuh.ku.edu.tr
Contact: Özlem Dikme, MD +905056487292 odikme@kuh.ku.edu.tr

Locations
Show Show 19 study locations
Sponsors and Collaborators
Emergency Medicine Association of Turkey
Investigators
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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

Additional Information:
Publications of Results:

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Responsible Party: Ekrem Musalar, Department of Emergency Medicine Koc University Hospital, Emergency Medicine Association of Turkey
ClinicalTrials.gov Identifier: NCT02637258    
Other Study ID Numbers: TATDUS-0001
First Posted: December 22, 2015    Key Record Dates
Last Update Posted: December 22, 2015
Last Verified: December 2015
Keywords provided by Ekrem Musalar, Emergency Medicine Association of Turkey:
optic nerve sheath diameter
neurological outcome
OHCA
Additional relevant MeSH terms:
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Neurologic Manifestations
Heart Arrest
Out-of-Hospital Cardiac Arrest
Heart Diseases
Cardiovascular Diseases
Nervous System Diseases
Signs and Symptoms