Can Optic Nerve Sheath Diameter Measurement Predict Negative Neurological Outcome ?

NCT02637258 | Unknown

• 1 other identifier: TATDUS-0001
• Study Type: observational
• Target: 203
• Locations: 1 country
• Sites: 19

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.

Conditions

Out of Hospital Cardiac Arrest; Neurologic Symptoms

Keywords

optic nerve sheath diameter; neurological outcome; OHCA

Outcome Measures

Primary Outcomes (1)

• Modified Rankin Scale (MRS).

  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 Outcomes (1)

• Neurological Examination

  72 hours after ROSC

Interventions

Ultrasonographic Measurements of Optic Nerve Sheath Diameter OTHER

Bedside Ultrasonographic Measurements of Optic Nerve Sheath Diameter

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Out-hospital cardiac arrest

You may not qualify if:

• In-hospital cardiac arrest
• Unstable patients requiring rapid intervention (i.e. emergent surgery, percutaneous coronary intervention)
• Age \<18
• Concomitant trauma
• Pregnancy
• 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)
• 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)
• Conditions causing increased production CSF (tumors), ventricular obstructions, cerebral edema, craniosynostosis
• Anatomical eye malformations preventing the USG examination
• Previously diagnosed malignity, glaucoma, multiple sclerosis, previously diagnosed terminal stage liver and renal disease,
• Cardiac arrest secondary to trauma and refusing to give consent to participate

Sponsors & Collaborators

• Emergency Medicine Association of Turkey: lead

Study Sites (19)

Başkent University

Adana, Turkey (Türkiye)

RECRUITING

Ankara Education and Research Hospital

Ankara, Turkey (Türkiye)

RECRUITING

Hacettepe University

Ankara, Turkey (Türkiye)

RECRUITING

Akdeniz University Hospital

Antalya, Turkey (Türkiye)

RECRUITING

Antalya Education and Research Hospital

Antalya, Turkey (Türkiye)

RECRUITING

Denizli State Hospital

Denizli, Turkey (Türkiye)

RECRUITING

Erzurum Education and Research Hospital

Erzurum, Turkey (Türkiye)

RECRUITING

Eskisehir Osmangazi University

Eskişehir, Turkey (Türkiye)

RECRUITING

Yunus Emre State Hospital

Eskişehir, Turkey (Türkiye)

RECRUITING

Istanbul Education and Research Hospital

Istanbul, Turkey (Türkiye)

RECRUITING

Istanbul Haseki Education and Research Hospital

Istanbul, Turkey (Türkiye)

RECRUITING

Istanbul Sıslı Hamidiye Etfal Education and Research Hospital

Istanbul, Turkey (Türkiye)

RECRUITING

Koç University Hospital

Istanbul, Turkey (Türkiye)

RECRUITING

Izmır University

Izmir, Turkey (Türkiye)

RECRUITING

Dokuz Eylul University

Izmır, Turkey (Türkiye)

RECRUITING

Ege University

Izmır, Turkey (Türkiye)

RECRUITING

Izmır Tepecik Education and Research Hospital

Izmır, Turkey (Türkiye)

RECRUITING

Kocaeli Derince Education and Research Hospital

Kocaeli, Turkey (Türkiye)

RECRUITING

Nevşehir State Hospital

Nevşehir, Turkey (Türkiye)

RECRUITING

Related Publications (10)

• Sasson C, Rogers MA, Dahl J, Kellermann AL. Predictors of survival from out-of-hospital cardiac arrest: a systematic review and meta-analysis. Circ Cardiovasc Qual Outcomes. 2010 Jan;3(1):63-81. doi: 10.1161/CIRCOUTCOMES.109.889576. Epub 2009 Nov 10.

  PMID: 20123673 RESULT

• McNally B, Robb R, Mehta M, Vellano K, Valderrama AL, Yoon PW, Sasson C, Crouch A, Perez AB, Merritt R, Kellermann A; Centers for Disease Control and Prevention. Out-of-hospital cardiac arrest surveillance --- Cardiac Arrest Registry to Enhance Survival (CARES), United States, October 1, 2005--December 31, 2010. MMWR Surveill Summ. 2011 Jul 29;60(8):1-19.

  PMID: 21796098 RESULT

• Maramattom BV, Wijdicks EF. Postresuscitation encephalopathy. Current views, management, and prognostication. Neurologist. 2005 Jul;11(4):234-43. doi: 10.1097/01.nrl.0000159985.07242.22.

  PMID: 15989696 RESULT

• Vaahersalo J, Bendel S, Reinikainen M, Kurola J, Tiainen M, Raj R, Pettila V, Varpula T, Skrifvars MB; FINNRESUSCI Study Group. Arterial blood gas tensions after resuscitation from out-of-hospital cardiac arrest: associations with long-term neurologic outcome. Crit Care Med. 2014 Jun;42(6):1463-70. doi: 10.1097/CCM.0000000000000228.

  PMID: 24557423 RESULT

• Fugate JE, Rabinstein AA, Claassen DO, White RD, Wijdicks EF. The FOUR score predicts outcome in patients after cardiac arrest. Neurocrit Care. 2010 Oct;13(2):205-10. doi: 10.1007/s12028-010-9407-5.

  PMID: 20645026 RESULT

• Hayashida K, Nishiyama K, Suzuki M, Abe T, Orita T, Ito N, Hori S. Estimated cerebral oxyhemoglobin as a useful indicator of neuroprotection in patients with post-cardiac arrest syndrome: a prospective, multicenter observational study. Crit Care. 2014 Aug 29;18(4):500. doi: 10.1186/s13054-014-0500-6.

  PMID: 25168063 RESULT

• Daubin C, Quentin C, Allouche S, Etard O, Gaillard C, Seguin A, Valette X, Parienti JJ, Prevost F, Ramakers M, Terzi N, Charbonneau P, du Cheyron D. Serum neuron-specific enolase as predictor of outcome in comatose cardiac-arrest survivors: a prospective cohort study. BMC Cardiovasc Disord. 2011 Aug 8;11:48. doi: 10.1186/1471-2261-11-48.

  PMID: 21824428 RESULT

• Hwan Kim Y, Ho Lee J, Kun Hong C, Won Cho K, Hoon Yeo J, Ju Kang M, Weon Kim Y, Yul Lee K, Joo Kim J, Youn Hwang S. Feasibility of optic nerve sheath diameter measured on initial brain computed tomography as an early neurologic outcome predictor after cardiac arrest. Acad Emerg Med. 2014 Oct;21(10):1121-8. doi: 10.1111/acem.12477.

  PMID: 25308135 RESULT

• Hassen GW, Bruck I, Donahue J, Mason B, Sweeney B, Saab W, Weedon J, Patel N, Perry K, Matari H, Jaiswal R, Kalantari H. Accuracy of optic nerve sheath diameter measurement by emergency physicians using bedside ultrasound. J Emerg Med. 2015 Apr;48(4):450-7. doi: 10.1016/j.jemermed.2014.09.060. Epub 2014 Dec 9.

  PMID: 25497897 RESULT

• Dubourg J, Javouhey E, Geeraerts T, Messerer M, Kassai B. Ultrasonography of optic nerve sheath diameter for detection of raised intracranial pressure: a systematic review and meta-analysis. Intensive Care Med. 2011 Jul;37(7):1059-68. doi: 10.1007/s00134-011-2224-2. Epub 2011 Apr 20.

  PMID: 21505900 RESULT

Related Links

• Standardized echography of the optic nerve
• Post-cardiac arrest syndrome: epidemiology, pathophysiology, treatment, and prognostication. A consensus statement from the International Liaison Committee on Resuscitation
• Utstein Collaborators

MeSH Terms

Conditions

Out-of-Hospital Cardiac Arrest; Neurologic Manifestations

Condition Hierarchy (Ancestors)

Heart Arrest; Heart Diseases; Cardiovascular Diseases; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• 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

  STUDY CHAIR

Central Study Contacts

Ekrem Musalar, MD

CONTACT

+905065742474; emusalar@kuh.ku.edu.tr

Özlem Dikme, MD

CONTACT

+905056487292; odikme@kuh.ku.edu.tr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Emergency Medicine Koc University Hospital

Study Record Dates

• First Submitted: December 15, 2015
• First Posted: December 22, 2015
• Study Start: December 1, 2015
• Primary Completion: February 1, 2017
• Study Completion: March 1, 2017
• Last Updated: December 22, 2015

Record last verified: 2015-12

Locations

TU (19)