An observational study in Delirium, Postoperative, Cardiac Disease and Cardiac Valve Disease, sponsored by Samsun University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2024-09-05.
Sponsored by Samsun University · Observational
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.
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.
788 studies on the registry are indexed under Emergence Delirium; 250 are open to participants now.
This study's enrollment of 90 is below the median of 154 across 288 observational studies indexed under Emergence Delirium.
Browse Emergence Delirium studies →Samsun University is the lead sponsor of 86 studies on the registry; 19 are open to participants now.
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Patients over the age of 18 who will undergo elective open heart surgery will be included in the study.
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Exclusion Criteria:
delirium positive
Diagnostic Test: ONSD
delirium negative
Diagnostic Test: ONSD
ultrasound measurement of the optic nerve sheath diameter
The relationship between ONSD and postoperative delirium in cardiac surgery
Peroperatively measured ONSD will be compared with the development of postoperative delirium.
Time frame: 6 months
Incidence of delirium after open heart surgery
Using the CAM-ICU test for delirium definition
Time frame: 6 months
Ran from Aug 2023 to primary completion in Jun 2024, 10 months.
Of 187 non-industry observational studies under Emergence Delirium, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 40. This study's 10 months is below that.
Counting every sponsor, half of 188 studies reached it within 20 months; a quarter within 10 and three quarters within 40.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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Samsun University