Association of Optic Nerve Sheath Diameter and Postoperative Delirium

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorLondon Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

About this trial

Postoperative delirium is a sudden and reversible disturbance of mental function, occurring after surgery, characterized by confusion, inattention, and fluctuating mental status, which can manifest as agitation or lethargy. It is a common post-operative complication, especially in older adults, and is associated with longer hospital stays and worse recovery outcomes. Validated delirium screening tools such as the Intensive Care Delirium Screening Checklist (ICDSC) and the Richmond Agitation and Sedation Scale (RASS) are widely used tools to assess delirium. However, the sensitivity of these screening tools can be variable when used in real-world practice and may miss early cases of delirium. The optic nerve sheath is a protective sheath that encloses part of the optic nerve that is located at the back of the eye. Measurement of the optic nerve sheath diameter is usually done using ultrasound to detect increased cranial pressure. Previous studies that have been conducted have shown that increased ONSD may be associated with occurrence of postoperative delirium. The purpose of this study is to determine if there is an association between optic nerve sheath diameter (ONSD) and the occurrence of delirium after surgery. This study will be conducted at the London Health Sciences Centre and will include 300 patients.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

A d u l t s ≥ 1 8 y e a r s .

Scheduled for cardiac surgery requiring cardiopulmonary bypass (CPB) (e.g., Coronary artery bypass graft (CABG), valve, combined procedures, aortic surgery).

Anticipated postoperative admission to the Cardiac ICU with expected stay >48 hours.

Preoperative ability to undergo ocular ultrasound examination (closed-eyelid scanning).

Disqualifiers

Known or suspected open-globe injury, penetrating ocular trauma, or intraocular foreign body.

Recent ocular surgery or intravitreal intervention within the past 6 weeks (if surgeon advises against periocular pressure).

Ocular conditions that invalidate ONSD measurement (e.g., severe proptosis, advanced optic neuropathies, orbital tumors) or obstruct ultrasound window (extensive periocular dressings, severe periorbital edema).

Known intracranial pathology expected to significantly alter baseline ONSD (e.g., large mass lesion with midline shift, obstructive hydrocephalus) or presence of external ventricular drain at baseline.

Trial design

Design model

Single group

Treatments tested in this trial

  • Optic nerve sheath diameter (ONSD) ultrasound

    Procedure/Surgery

    Optic nerve sheath diameter (ONSD) ultrasound to be performed to measure diameter of the optic nerve sheath. Administration of the Intensive Care Delirium Screening Checklist (ICDSC) twice daily until discharge from the ICU.

Treatment groups

300 Participants
are divided into 1 treatment group
Group A: Optic nerve sheath diameter (ONSD) ultrasoundExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Impact of optic nerve sheath diameter on postoperative delirium

This will be measured by comparing the diameter of the optic nerve sheath to the results of the Intensive Care Delirium Screening Checklist (ICDSC) that will be used to measure delirium in patients. The ICDSC will provide a score of 0-8 for patients. Scores of 4 or higher will be considered to be indicative of postoperative delirium.

Time frame
Days 1-3 postoperatively

Secondary outcomes

1

Impact of optic nerve sheath diameter on hospital length of stay

This will be measured by noting how long the patient is in hospital following surgery and comparing that to optic nerve sheath diameter.

Time frame
Days 1-7 postoperatively
2

Impact of optic nerve sheath diameter on mortality

This will be measured by noting if a participant has died and comparing that to optic nerve sheath diameter.

Time frame
Days 1-7 postoperatively
3

Impact of optic nerve sheath diameter on time spent on a ventilator

This will be measured by noting how long the patient is required to use a ventilator (if applicable) following surgery and comparing that to optic nerve sheath diameter.

Time frame
Days 1-7 postoperatively
4

Impact of optic nerve sheath diameter on the need for re-intubation

This will be measured by noting if a participant requires re-intubation following surgery and comparing that to optic nerve sheath diameter.

Time frame
Days 1-7 postoperatively

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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