Optic Nerve Sheath After Extracorporeal Circulation

Cardiac Disease Clinical Trial

Official title:

The Influence of Extracorporeal Circulation During Cardiac Surgery on Optic Nerve Sheath Diameter

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05335902
• Other study ID #: UKC-MB-KME-59/21
• Status: Recruiting
• Start date: November 22, 2021
• Est. completion date: June 2023

Study information

• Verified date: December 2022
• Source: University Medical Centre Maribor
• Contact: Andreja Möller Petrun, PhD
• Phone: 38623211571
• Email: drejapet[@]web.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to assess the influence of extracorporeal circulation during cardiac surgery on the optic nerve sheath diameter (ONSD) after the surgery.

Description:

ONSD will be measured before and 1 hour after the surgery and in the morning of day 1 after the surgery. Fluid balance and lactate will be measured too. PONV will be assessed. Patients will be evaluated with MoCA test on the day before surgery and on the day 3 after the surgery for cognitive disfunction.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 2023
• Est. primary completion date: February 2023
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• heart surgery with use of cardiopulmonary bypass

Exclusion Criteria:

• pregnancy and lactation

• neurologic disorders

• hyperthyroidism

• optic nerve disorders

Related Conditions & MeSH terms

• Cardiac Disease
• Cardiac Valve Disease
• Heart Diseases
• Heart Valve Diseases

Intervention

Diagnostic Test:
• ultrasound measurement of the optic nerve sheath diameter
ultrasound measurement of the optic nerve sheath diameter
• MoCA test
MoCA test is a short bedside test for measuring cognitive disfunction

Locations

Country	Name	City	State
Slovenia	University medical centre Maribor	Maribor

Sponsors (1)

Lead Sponsor	Collaborator
University Medical Centre Maribor

Country where clinical trial is conducted

Slovenia, 

References & Publications (26)

Aduayi OS, Asaleye CM, Adetiloye VA, Komolafe EO, Aduayi VA. Optic nerve sonography: A noninvasive means of detecting raised intracranial pressure in a resource-limited setting. J Neurosci Rural Pract. 2015 Oct-Dec;6(4):563-7. doi: 10.4103/0976-3147.165347. — View Citation

Ali MA, Hashmi M, Shamim S, Salam B, Siraj S, Salim B. Correlation of Optic Nerve Sheath Diameter with Direct Measurement of Intracranial Pressure through an External Ventricular Drain. Cureus. 2019 Sep 26;11(9):e5777. doi: 10.7759/cureus.5777. — View Citation

Barbosa Nde F, Cardinelli DM, Ercole FF. Determinants of neurological complications with the use of extracorporeal circulation (ECC). Arq Bras Cardiol. 2010 Dec;95(6):e151-7. doi: 10.1590/s0066-782x2010001600022. No abstract available. English, Portuguese, Spanish. — View Citation

Bayram H, Hidiroglu M, Cetin L, Kucuker A, Iriz E, Uguz E, Saglam F, Sener E. Comparing S-100 beta protein levels and neurocognitive functions between patients undergoing on-pump and off-pump coronary artery bypass grafting. J Surg Res. 2013 Jun 15;182(2):198-202. doi: 10.1016/j.jss.2012.10.047. Epub 2012 Nov 9. — View Citation

Chen H, Ding GS, Zhao YC, Yu RG, Zhou JX. Ultrasound measurement of optic nerve diameter and optic nerve sheath diameter in healthy Chinese adults. BMC Neurol. 2015 Jul 7;15:106. doi: 10.1186/s12883-015-0361-x. — View Citation

Cheung AT, Messe SR. Preventing Brain Injury After Cardiopulmonary Bypass Will Require More Than Just Dialing Up the Pressure. Circulation. 2018 Apr 24;137(17):1781-1783. doi: 10.1161/CIRCULATIONAHA.118.033197. No abstract available. — View Citation

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. — View Citation

Evensen KB, Eide PK. Measuring intracranial pressure by invasive, less invasive or non-invasive means: limitations and avenues for improvement. Fluids Barriers CNS. 2020 May 6;17(1):34. doi: 10.1186/s12987-020-00195-3. — View Citation

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Harris DN, Bailey SM, Smith PL, Taylor KM, Oatridge A, Bydder GM. Brain swelling in first hour after coronary artery bypass surgery. Lancet. 1993 Sep 4;342(8871):586-7. doi: 10.1016/0140-6736(93)91412-f. — View Citation

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Selnes OA, Goldsborough MA, Borowicz LM, McKhann GM. Neurobehavioural sequelae of cardiopulmonary bypass. Lancet. 1999 May 8;353(9164):1601-6. doi: 10.1016/S0140-6736(98)07576-X. — View Citation

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Yilmaz G, Akca A, Kiyak H, Salihoglu Z. Elevation in optic nerve sheath diameter due to the pneumoperitoneum and Trendelenburg is associated to postoperative nausea, vomiting and headache in patients undergoing laparoscopic hysterectomy. Minerva Anestesiol. 2020 Mar;86(3):270-276. doi: 10.23736/S0375-9393.19.13920-X. Epub 2019 Oct 28. — View Citation

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* Note: There are 26 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ultrasound measuring of optic nerve sheath diameter baseline	Baseline optic nerve sheath diameter measurement before start of surgery with a linear ultrasound probe (Scan) in coronal and axial plane	Before start of surgery
Primary	Ultrasound measuring of optic nerve sheath diameter end of surgery	Optic nerve sheath diameter measurement 1 hour after the end of surgery with a linear ultrasound probe in coronal and axial plane	1 hour after the end of surgery
Primary	Ultrasound measuring of optic nerve sheath diameter day 1	Optic nerve sheath diameter measurement in the morning on day 1 after the surgery with a linear ultrasound probe in coronal and axial plane	day 1 after the surgery
Secondary	postoperative cognitive disfunction measured with the MoCA test	MoCA test is a validated test for cognitive disfunction, especially in patients who are elderly than 60 years, the study is comparing the MoCA test values on the day before surgery with the values on day 3 after the surgery	on the day before surgery, on day 3 after the surgery
Secondary	postoperative nausea and vomiting (PONV)	Postoperative nausea and vomiting is common after cardiac surgery, the occurrence of postoperative nausea and vomiting will be recorded	during the first 24 hours after surgery