Optic Nerve Sheath Diameter is Associated With Postoperative Delirium in Patients Undergoing Open Heart Surgery

September 1, 2024 updated by: Aynur Kaynar, Samsun University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Samsun, Turkey, 55270
        • Aynur Kaynar

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
CAM-ICU positive
delirium positive
Diagnostic test: ONSD
ultrasound measurement of the optic nerve sheath diameter
CAM-ICU negative
delirium negative
Diagnostic test: ONSD
ultrasound measurement of the optic nerve sheath diameter

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Samsun University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 7, 2023

Primary Completion (Actual)

June 12, 2024

Study Completion (Actual)

June 12, 2024

Study Registration Dates

First Submitted

June 13, 2023

First Submitted That Met QC Criteria

July 3, 2023

First Posted (Actual)

July 12, 2023

Study Record Updates

Last Update Posted (Estimated)

September 5, 2024

Last Update Submitted That Met QC Criteria

September 1, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SÜKAEK-2023 11/7

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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