The Relationship Between Optic Nerve Sheath Diameter and Postoperative Delirium in Open Heart Surgery

Cardiac Disease Clinical Trial

Official title:

The Relationship Between Optic Nerve Sheath Diameter and Postoperative Delirium in Open Heart Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05942183
• Other study ID #: SÜKAEK-2023 11/7
• Status: Recruiting
• Start date: August 7, 2023
• Est. completion date: August 30, 2024

Study information

• Verified date: April 2024
• Source: Samsun University
• Contact: Aynur Kaynar
• Phone: +90 505 765 53 24
• Email: aynurkaynar_[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Although the incidence of delirium after cardiac surgery is high, it is not sufficiently recognized. The long-term effects of delirium are likely to be underestimated. In this study, the investigators aimed to examine the relationship between optic nerve sheath diameter and postoperative delirium in open hearth surgery.

Description:

Postoperative delirium is characterized by widespread brain involvement and its incidence is between 6% and 30%. It appears twice as often after cardiac and vascular surgery than other types of surgery. The correlation between optic nerve sheath diameter (ONSD) and invasive intracranial pressure measurement is excellent. ONSD reduction has the potential to indicate intracranial hypoperfusion causing delirium. In this observational study, patients aged 18 years and over who will undergo open heart surgery will be examined. ONSD will be measured using ultrasound five times in the perioperative period (t0: pre-induction, t1: post-induction, t2: onset of cardiopulmonary bypass (CPB), t3: post-CPB, and t4: post-ICU admission). The Confusion Assessment Method for the ICU (CAM-ICU) test will be used to examine delirium in the ICU. Whether the change in ONSD is an independent risk factor for delirium will be evaluated.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: August 30, 2024
• Est. primary completion date: May 20, 2024
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• =18 year old
• Elective open heart surgery

Exclusion Criteria:

• psychiatric illness
• neurological disease
• ophthalmic disease
• previous eye surgery
• perioperative cerebrovascular disease
• need for postoperative intraaortic balloon or extracorporeal support system

Related Conditions & MeSH terms

• Cardiac Disease
• Cardiac Valve Disease
• Delirium
• Delirium, Postoperative
• Emergence Delirium
• Heart Diseases
• Heart Valve Diseases

Intervention

Diagnostic Test:
• ONSD
ultrasound measurement of the optic nerve sheath diameter

Locations

Country	Name	City	State
Turkey	Aynur Kaynar	Samsun

Sponsors (1)

Lead Sponsor	Collaborator
Samsun University

Country where clinical trial is conducted

Turkey, 

References & Publications (4)

Heyer EJ, DeLaPaz R, Halazun HJ, Rampersad A, Sciacca R, Zurica J, Benvenisty AI, Quest DO, Todd GJ, Lavine S, Solomon RA, Connolly ES Jr. Neuropsychological dysfunction in the absence of structural evidence for cerebral ischemia after uncomplicated carotid endarterectomy. Neurosurgery. 2006 Mar;58(3):474-80; discussion 474-80. doi: 10.1227/01.NEU.0000197123.09972.EA. — View Citation

Sekhon MS, Griesdale DE, Robba C, McGlashan N, Needham E, Walland K, Shook AC, Smielewski P, Czosnyka M, Gupta AK, Menon DK. Optic nerve sheath diameter on computed tomography is correlated with simultaneously measured intracranial pressure in patients with severe traumatic brain injury. Intensive Care Med. 2014 Sep;40(9):1267-74. doi: 10.1007/s00134-014-3392-7. Epub 2014 Jul 18. Erratum In: Intensive Care Med. 2015 Jan;41(1):177. Intensive Care Med. 2015 Jan;41(1):177. — View Citation

Smith W, Whitlock EL. Cardiac surgery, ICU sedation, and delirium: is dexmedetomidine the silver bullet? Curr Opin Anaesthesiol. 2023 Feb 1;36(1):50-56. doi: 10.1097/ACO.0000000000001207. Epub 2022 Nov 7. — View Citation

Zhang X, Medow JE, Iskandar BJ, Wang F, Shokoueinejad M, Koueik J, Webster JG. Invasive and noninvasive means of measuring intracranial pressure: a review. Physiol Meas. 2017 Jul 24;38(8):R143-R182. doi: 10.1088/1361-6579/aa7256. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The relationship between ONSD and postoperative delirium in cardiac surgery	Peroperatively measured ONSD will be compared with the development of postoperative delirium.	6 months
Primary	Incidence of delirium after open heart surgery	Using the CAM-ICU test for delirium definition	6 months