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

Sponsor
Samsun University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05942183
Collaborator
(none)
40
1
6.4
6.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: ONSD

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 Design

Study Type:
Observational
Anticipated Enrollment :
40 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
The Relationship Between Optic Nerve Sheath Diameter and Postoperative Delirium in Open Heart Surgery
Anticipated Study Start Date :
Jul 20, 2023
Anticipated Primary Completion Date :
Jan 20, 2024
Anticipated Study Completion Date :
Jan 31, 2024

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. The relationship between ONSD and postoperative delirium in cardiac surgery [6 months]

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

  2. Incidence of delirium after open heart surgery [6 months]

    Using the CAM-ICU test for delirium definition

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 90 Years
Sexes Eligible for Study:
All
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Aynur Kaynar Samsun Turkey 55270

Sponsors and Collaborators

  • Samsun University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Aynur Kaynar, principle investigator, Samsun University
ClinicalTrials.gov Identifier:
NCT05942183
Other Study ID Numbers:
  • SÜKAEK-2023 11/7
First Posted:
Jul 12, 2023
Last Update Posted:
Jul 12, 2023
Last Verified:
Jul 1, 2023
Keywords provided by Aynur Kaynar, principle investigator, Samsun University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 12, 2023