NCT05942183

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2023

Shorter than P25 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

June 13, 2023

Completed
29 days until next milestone

First Posted

Study publicly available on registry

July 12, 2023

Completed
26 days until next milestone

Study Start

First participant enrolled

August 7, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 12, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 12, 2024

Completed
Last Updated

September 5, 2024

Status Verified

September 1, 2024

Enrollment Period

10 months

First QC Date

June 13, 2023

Last Update Submit

September 1, 2024

Conditions

Delirium, PostoperativeCardiac DiseaseCardiac Valve Disease

Keywords

optic nerve sheath diametercardiac surgeryultrasound

Outcome Measures

Primary Outcomes (2)

  • The relationship between ONSD and postoperative delirium in cardiac surgery

    Peroperatively measured ONSD will be compared with the development of postoperative delirium.

    6 months

  • Incidence of delirium after open heart surgery

    Using the CAM-ICU test for delirium definition

    6 months

Study Arms (2)

CAM-ICU positive

delirium positive

Diagnostic Test: ONSD

CAM-ICU negative

delirium negative

Diagnostic Test: ONSD

Interventions

ONSDDIAGNOSTIC_TEST

ultrasound measurement of the optic nerve sheath diameter

CAM-ICU negativeCAM-ICU positive

Eligibility Criteria

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

Patients over the age of 18 who will undergo elective open heart surgery will be included in the study.

You may qualify if:

  • ≥18 year old
  • Elective open heart surgery

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aynur Kaynar

Samsun, 55270, Turkey (Türkiye)

Location

Related Publications (5)

  • 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.

    PMID: 16528187BACKGROUND

  • 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.

    PMID: 36342329BACKGROUND

  • 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.

    PMID: 28489610BACKGROUND

  • 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.

    PMID: 25034476BACKGROUND

  • Kaynar A, Komurcu O, Bahsi E, Aydin AO, Karal IH, Akyurt D, Tulgar S, Suren M. Optic nerve sheath diameter is associated with postoperative delirium in patients undergoing open heart surgery. BMC Anesthesiol. 2025 Jul 1;25(1):309. doi: 10.1186/s12871-025-03194-9.

    PMID: 40596877DERIVED

MeSH Terms

Conditions

Emergence DeliriumHeart DiseasesHeart Valve Diseases

Condition Hierarchy (Ancestors)

DeliriumConfusionNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and SymptomsNeurocognitive DisordersMental DisordersCardiovascular Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principle investigator

Study Record Dates

First Submitted

June 13, 2023

First Posted

July 12, 2023

Study Start

August 7, 2023

Primary Completion

June 12, 2024

Study Completion

June 12, 2024

Last Updated

September 5, 2024

Record last verified: 2024-09

Locations

TU(1)