Delirium, PostoperativeNCT05942183
Optic Nerve Sheath Diameter is Associated With Postoperative Delirium in Patients Undergoing Open Heart Surgery
An observational study of Delirium, Postoperative and Cardiac Disease, run by Samsun University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Delirium, Postoperative, Cardiac Disease, Cardiac Valve Disease
- What is being tested?
- ONSD
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 7 Aug 2023to 12 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Adult, Older adult
Study population: Patients over the age of 18 who will undergo elective open heart surgery will be included in the study.
Who may be able to join
- ≥18 year old
- Elective open heart surgery
Who cannot join
- psychiatric illness
- neurological disease
- ophthalmic disease
- previous eye surgery
- perioperative cerebrovascular disease
- need for postoperative intraaortic balloon or extracorporeal support system
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- ONSD
- Keywords
- optic nerve sheath diameter, cardiac surgery, ultrasound
- Medical subject headings
- Emergence Delirium, Heart Diseases, Heart Valve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ONSDDiagnostic test
ultrasound measurement of the optic nerve sheath diameter
| Study group | Role | What they receive |
|---|---|---|
| CAM-ICU positive | delirium positive Receives: Diagnostic Test: ONSD | |
| CAM-ICU negative | delirium negative Receives: Diagnostic Test: ONSD |
What is being measured
The primary outcome is the main question the study is designed to answer.
The relationship between ONSD and postoperative delirium in cardiac surgery
Peroperatively measured ONSD will be compared with the development of postoperative delirium.
Measured: 6 months
Incidence of delirium after open heart surgery
Using the CAM-ICU test for delirium definition
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2023
- Study start7 Aug 2023
- Primary completion12 Jun 2024
- Study completion12 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Delirium, PostoperativeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsun University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aynur Kaynar, Samsun University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05942183
- Sponsor's protocol ID
- SÜKAEK-2023 11/7
- Status last verified
- Sep 2024
- First submitted
- 13 Jun 2023
- Last updated
- 5 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Heyer EJ, DeLaPaz R, Halazun HJ, Rampersad A, Sciacca R, Zurica J, Benvenisty AI, Quest DO, Todd GJ, Lavine S, Solomon RA, Connolly ES Jr. Neuropsychological dysfunction in the absence of structural evidence for cerebral ischemia after uncomplicated carotid endarterectomy. Neurosurgery. 2006 Mar;58(3):474-80; discussion 474-80. doi: 10.1227/01.NEU.0000197123.09972.EA.
PubMed 16528187Smith W, Whitlock EL. Cardiac surgery, ICU sedation, and delirium: is dexmedetomidine the silver bullet? Curr Opin Anaesthesiol. 2023 Feb 1;36(1):50-56. doi: 10.1097/ACO.0000000000001207. Epub 2022 Nov 7.
PubMed 36342329Zhang X, Medow JE, Iskandar BJ, Wang F, Shokoueinejad M, Koueik J, Webster JG. Invasive and noninvasive means of measuring intracranial pressure: a review. Physiol Meas. 2017 Jul 24;38(8):R143-R182. doi: 10.1088/1361-6579/aa7256.
PubMed 28489610Sekhon MS, Griesdale DE, Robba C, McGlashan N, Needham E, Walland K, Shook AC, Smielewski P, Czosnyka M, Gupta AK, Menon DK. Optic nerve sheath diameter on computed tomography is correlated with simultaneously measured intracranial pressure in patients with severe traumatic brain injury. Intensive Care Med. 2014 Sep;40(9):1267-74. doi: 10.1007/s00134-014-3392-7. Epub 2014 Jul 18.
PubMed 25034476Kaynar A, Komurcu O, Bahsi E, Aydin AO, Karal IH, Akyurt D, Tulgar S, Suren M. Optic nerve sheath diameter is associated with postoperative delirium in patients undergoing open heart surgery. BMC Anesthesiol. 2025 Jul 1;25(1):309. doi: 10.1186/s12871-025-03194-9.
PubMed 40596877
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Optic Nerve Sheath Diameter and Postoperative Delirium in Open Heart Surgery
- ClinicalTrials.gov ID
- NCT05942183
- Acronym / sponsor ID
- SÜKAEK-2023 11/7
- Keywords
- optic nerve sheath diameter, cardiac surgery, ultrasound
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Samsun UniversityUniversity, hospital or other
- Study start
- 7 Aug 2023 (actual)
- Primary completion
- 12 Jun 2024 (actual)
- Study completion
- 12 Jun 2024 (actual)
- First posted
- 12 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CAM-ICU positive | – | Diagnostic Test: ONSDdelirium positive |
| CAM-ICU negative | – | Diagnostic Test: ONSDdelirium negative |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients over the age of 18 who will undergo elective open heart surgery will be included in the study.
Key inclusion criteria (2 listed)
- ≥18 year old
- Elective open heart surgery
Key exclusion criteria (6 listed)
- psychiatric illness
- neurological disease
- ophthalmic disease
- previous eye surgery
- perioperative cerebrovascular disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ONSDultrasound measurement of the optic nerve sheath diameter | Diagnostic test | CAM-ICU negative, CAM-ICU positive |
Primary outcome
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.
Incidence of delirium after open heart surgery
Time frame: 6 months
Using the CAM-ICU test for delirium definition
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2024.
- Background: PubMed 16528187Heyer EJ, DeLaPaz R, Halazun HJ, Rampersad A, Sciacca R, Zurica J, Benvenisty AI, Quest DO, Todd GJ, Lavine S, Solomon RA, Connolly ES Jr. Neuropsychological dysfunction in the absence of structural evidence for cerebral ischemia after uncomplicated carotid endarterectomy. Neurosurgery. 2006 Mar;58(3):474-80; discussion 474-80. doi: 10.1227/01.NEU.0000197123.09972.EA.
- Background: PubMed 36342329Smith W, Whitlock EL. Cardiac surgery, ICU sedation, and delirium: is dexmedetomidine the silver bullet? Curr Opin Anaesthesiol. 2023 Feb 1;36(1):50-56. doi: 10.1097/ACO.0000000000001207. Epub 2022 Nov 7.
- Background: PubMed 28489610Zhang X, Medow JE, Iskandar BJ, Wang F, Shokoueinejad M, Koueik J, Webster JG. Invasive and noninvasive means of measuring intracranial pressure: a review. Physiol Meas. 2017 Jul 24;38(8):R143-R182. doi: 10.1088/1361-6579/aa7256.
- Background: PubMed 25034476Sekhon MS, Griesdale DE, Robba C, McGlashan N, Needham E, Walland K, Shook AC, Smielewski P, Czosnyka M, Gupta AK, Menon DK. Optic nerve sheath diameter on computed tomography is correlated with simultaneously measured intracranial pressure in patients with severe traumatic brain injury. Intensive Care Med. 2014 Sep;40(9):1267-74. doi: 10.1007/s00134-014-3392-7. Epub 2014 Jul 18.
- Derived from this study: PubMed 40596877Kaynar A, Komurcu O, Bahsi E, Aydin AO, Karal IH, Akyurt D, Tulgar S, Suren M. Optic nerve sheath diameter is associated with postoperative delirium in patients undergoing open heart surgery. BMC Anesthesiol. 2025 Jul 1;25(1):309. doi: 10.1186/s12871-025-03194-9.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Delirium, Postoperative and Cardiac Disease, run by Samsun University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The relationship between ONSD and postoperative delirium in cardiac surgery (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05942183, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2024.