NCT05335902

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 29, 2021

Completed
24 days until next milestone

Study Start

First participant enrolled

November 22, 2021

Completed
5 months until next milestone

First Posted

Study publicly available on registry

April 20, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2023

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
Last Updated

August 5, 2024

Status Verified

August 1, 2024

Enrollment Period

1.2 years

First QC Date

October 29, 2021

Last Update Submit

August 2, 2024

Conditions

Cardiac DiseaseCardiac Valve Disease

Keywords

extracorporeal circulationotpic nerve sheath diameterpostoperative cognitive disfunctionpostoperative nausea and vomiting

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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 Outcomes (2)

  • postoperative cognitive disfunction measured with the MoCA test

    on the day before surgery, on day 3 after the surgery

  • postoperative nausea and vomiting (PONV)

    during the first 24 hours after surgery

Study Arms (2)

standard cardiopulmonary bypass

patients 18 year or older undergoing heart surgery with standard cardiopulmonary bypass

Diagnostic Test: ultrasound measurement of the optic nerve sheath diameterDiagnostic Test: MoCA test

mini-cardiopulmonary bypass

patients 18 year or older undergoing heart surgery with standard mini-cardiopulmonary bypass

Diagnostic Test: ultrasound measurement of the optic nerve sheath diameterDiagnostic Test: MoCA test

Interventions

ultrasound measurement of the optic nerve sheath diameterDIAGNOSTIC_TEST

ultrasound measurement of the optic nerve sheath diameter

mini-cardiopulmonary bypassstandard cardiopulmonary bypass
MoCA testDIAGNOSTIC_TEST

MoCA test is a short bedside test for measuring cognitive disfunction

mini-cardiopulmonary bypassstandard cardiopulmonary bypass

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients 18 years or older which are scheduled for heart surgery (coronary bypass, valve disease, thoracic aortic disease) in which cardiopulmonary bypass is used.

You may qualify if:

  • heart surgery with use of cardiopulmonary bypass

You may not qualify if:

  • pregnancy and lactation
  • neurologic disorders
  • hyperthyroidism
  • optic nerve disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University medical centre Maribor

Maribor, 2000, Slovenia

Location

Related Publications (26)

  • Roach GW, Kanchuger M, Mangano CM, Newman M, Nussmeier N, Wolman R, Aggarwal A, Marschall K, Graham SH, Ley C. Adverse cerebral outcomes after coronary bypass surgery. Multicenter Study of Perioperative Ischemia Research Group and the Ischemia Research and Education Foundation Investigators. N Engl J Med. 1996 Dec 19;335(25):1857-63. doi: 10.1056/NEJM199612193352501.

    PMID: 8948560BACKGROUND

  • 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.

    PMID: 10334272BACKGROUND

  • Zamvar V, Williams D, Hall J, Payne N, Cann C, Young K, Karthikeyan S, Dunne J. Assessment of neurocognitive impairment after off-pump and on-pump techniques for coronary artery bypass graft surgery: prospective randomised controlled trial. BMJ. 2002 Nov 30;325(7375):1268. doi: 10.1136/bmj.325.7375.1268.

    PMID: 12458242BACKGROUND

  • 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.

    PMID: 23183054BACKGROUND

  • Stroobant N, Van Nooten G, Belleghem Y, Vingerhoets G. Short-term and long-term neurocognitive outcome in on-pump versus off-pump CABG. Eur J Cardiothorac Surg. 2002 Oct;22(4):559-64. doi: 10.1016/s1010-7940(02)00409-8.

    PMID: 12297172BACKGROUND

  • Riha H, Drabek T, Polisenska J, Brezina A. Postoperative nausea and vomiting in cardiac surgery. Eur J Anaesthesiol. 2009 Jun;26(6):535-6. doi: 10.1097/eja.0b013e328320a67a. No abstract available.

    PMID: 19445063BACKGROUND

  • Gong Z, Li J, Zhong Y, Guan X, Huang A, Ma L. Effects of dexmedetomidine on postoperative cognitive function in patients undergoing coronary artery bypass grafting. Exp Ther Med. 2018 Dec;16(6):4685-4689. doi: 10.3892/etm.2018.6778. Epub 2018 Sep 19.

    PMID: 30542420BACKGROUND

  • Styra R, Larsen E, Dimas MA, Baston D, Elgie-Watson J, Flockhart L, Lindsay TF. The effect of preoperative cognitive impairment and type of vascular surgery procedure on postoperative delirium with associated cost implications. J Vasc Surg. 2019 Jan;69(1):201-209. doi: 10.1016/j.jvs.2018.05.001. Epub 2018 Jun 22.

    PMID: 29941317BACKGROUND

  • O'Dwyer C, Prough DS, Johnston WE. Determinants of cerebral perfusion during cardiopulmonary bypass. J Cardiothorac Vasc Anesth. 1996 Jan;10(1):54-64; quiz 65. doi: 10.1016/s1053-0770(96)80179-0.

    PMID: 8634388BACKGROUND

  • 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.

    PMID: 21271187BACKGROUND

  • Salameh A, Dhein S, Dahnert I, Klein N. Neuroprotective Strategies during Cardiac Surgery with Cardiopulmonary Bypass. Int J Mol Sci. 2016 Nov 21;17(11):1945. doi: 10.3390/ijms17111945.

    PMID: 27879647BACKGROUND

  • Murphy GJ, Angelini GD. Side effects of cardiopulmonary bypass: what is the reality? J Card Surg. 2004 Nov-Dec;19(6):481-8. doi: 10.1111/j.0886-0440.2004.04101.x.

    PMID: 15548178BACKGROUND

  • Hirleman E, Larson DF. Cardiopulmonary bypass and edema: physiology and pathophysiology. Perfusion. 2008 Nov;23(6):311-22. doi: 10.1177/0267659109105079.

    PMID: 19454559BACKGROUND

  • Ottens TH, Hendrikse J, Slooter AJ, van Herwerden LA, Dieleman JM, van Dijk D. Low incidence of early postoperative cerebral edema after coronary artery bypass grafting. J Cardiothorac Vasc Anesth. 2015;29(3):632-6. doi: 10.1053/j.jvca.2014.12.004. Epub 2014 Dec 3.

    PMID: 25817849BACKGROUND

  • Harris DN, Oatridge A, Dob D, Smith PL, Taylor KM, Bydder GM. Cerebral swelling after normothermic cardiopulmonary bypass. Anesthesiology. 1998 Feb;88(2):340-5. doi: 10.1097/00000542-199802000-00011.

    PMID: 9477053BACKGROUND

  • 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.

    PMID: 8102722BACKGROUND

  • Linardi D, Walpoth B, Mani R, Murari A, Tessari M, Hoxha S, Anderloni M, Decimo I, Dolci S, Nicolato E, Bontempi P, Merigo F, Luciani GB, Faggian G, Rungatscher A. Slow versus fast rewarming after hypothermic circulatory arrest: effects on neuroinflammation and cerebral oedema. Eur J Cardiothorac Surg. 2020 Oct 1;58(4):792-800. doi: 10.1093/ejcts/ezaa143.

    PMID: 32408343BACKGROUND

  • 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.

    PMID: 29685929BACKGROUND

  • 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.

    PMID: 32375853BACKGROUND

  • 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.

    PMID: 26148482BACKGROUND

  • 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: 21505900BACKGROUND

  • 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.

    PMID: 26752428BACKGROUND

  • Tawfik EA, Walker FO, Cartwright MS. Neuromuscular ultrasound of cranial nerves. J Clin Neurol. 2015 Apr;11(2):109-21. doi: 10.3988/jcn.2015.11.2.109.

    PMID: 25851889BACKGROUND

  • 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.

    PMID: 31723536BACKGROUND

  • 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.

    PMID: 31680498BACKGROUND

  • Hu J, Li CJ, Wang BJ, Li XY, Mu DL, Wang DX. The sensitivity and specificity of statistical rules for diagnosing delayed neurocognitive recovery with Montreal cognitive assessment in elderly surgical patients: A cohort study. Medicine (Baltimore). 2020 Jul 17;99(29):e21193. doi: 10.1097/MD.0000000000021193.

    PMID: 32702882BACKGROUND

MeSH Terms

Conditions

Heart DiseasesHeart Valve DiseasesPostoperative Nausea and Vomiting

Condition Hierarchy (Ancestors)

Cardiovascular DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsNauseaSigns and Symptoms, DigestiveSigns and SymptomsVomiting

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 29, 2021

First Posted

April 20, 2022

Study Start

November 22, 2021

Primary Completion

February 1, 2023

Study Completion

June 1, 2024

Last Updated

August 5, 2024

Record last verified: 2024-08

Locations

SL(1)