Clinical trial NCT05942183: Optic Nerve Sheath Diameter is Associated With Postoperative Delirium in Patients Undergoing Open Heart Surgery
Official title: The Relationship Between Optic Nerve Sheath Diameter and Postoperative Delirium in Open Heart Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Delirium, Postoperative
Cardiac Disease
Cardiac Valve Disease
Keywords: optic nerve sheath diameter
cardiac surgery
ultrasound
Lead sponsor: Samsun University
Sponsor class: OTHER
First posted: 2023-07-12
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients over the age of 18 who will undergo elective open heart surgery will be included in the study.

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: The relationship between ONSD and postoperative delirium in cardiac surgery
timeFrame: 6 months
measure: Incidence of delirium after open heart surgery
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Samsun
country: Turkey
facility: Aynur Kaynar
Study officials:
References:
citation: 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.
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.
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.
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.