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Completed

NCT Number: NCT05942183

Optic Nerve Sheath Diameter is Associated With Postoperative Delirium in Patients Undergoing 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.

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Key information

Conditions

Delirium, Postoperative Cardiac Disease Cardiac Valve Disease Cardiovascular Diseases Confusion Delirium Emergence Delirium Heart Diseases Heart Valve Diseases Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Aynur Kaynar

Samsun, 55270, Turkey (Türkiye)

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ONSD

Diagnostic Test

ultrasound measurement of the optic nerve sheath diameter

Primary outcomes

  1. 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.

  2. Incidence of delirium after open heart surgery

    Time frame: 6 months

    Using the CAM-ICU test for delirium definition

Sponsors and collaborators

Lead sponsor

Samsun University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jul 12, 2023
Registry last updated
Sep 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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