Open Heart SurgeryNCT07253922
Evaluation of Optic Nerve Sheath Diameter Changes During Cardiopulmonary Bypass in Open Heart Surgery
An observational study of Open Heart Surgery and Cardiopulmonary Bypass, run by Medipol University at 1 site in Turkey (Türkiye).
Trial summary
During cardiopulmonary bypass (CPB) in open-heart surgery, direct measurement of intracranial pressure is not feasible. Evaluation of the optic nerve sheath diameter (ONSD) by ultrasonography is considered a reliable method for predicting increases in intracranial pressure. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Open Heart Surgery, Cardiopulmonary Bypass, Intracranial Pressure
- What is being tested?
- Ultrasonography of the Optic Nerve Sheath
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Jun 2025to 25 Nov 2025
- 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 85 years
- All sexes
- Adult, Older adult
Study population: Adult patients (18-85 years) undergoing elective open-heart surgery with cardiopulmonary bypass at Istanbul Medipol University Hospital, who meet inclusion criteria and provide written informed consent.
Who may be able to join
- Adults aged 18-85 years
- Scheduled for elective open-heart surgery with cardiopulmonary bypass
- Provided written informed consent
Who cannot join
- Ocular or neurological complications related to diabetes
- History of previous eye, brain, or thoracic surgery
- Diagnosis of hydrocephalus, glaucoma, intracranial mass, or stroke
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Evaluation of Optic Nerve Sheath Diameter Changes Measured by Ultrasonography During Cardiopulmonary Bypass in Patients Undergoing Open Heart Surgery
During cardiopulmonary bypass (CPB) in open-heart surgery, direct measurement of intracranial pressure is not feasible. Evaluation of the optic nerve sheath diameter (ONSD) by ultrasonography is considered a reliable method for predicting increases in intracranial pressure. This study aims to investigate changes in ONSD in patients undergoing open-heart surgery with CPB.
Read the detailed description
Several mechanisms during CPB-including inflammatory response, hemodilution, reperfusion injury, hypothermia-rewarming imbalances, and microembolism formation-can lead to increased intracranial pressure and cerebral edema. Ultrasonographic measurement of ONSD provides a noninvasive means of monitoring these changes. In this study, ONSD will be measured at different time points, while hemodynamic parameters, NIRS values, and arterial blood gas analyses will be recorded simultaneously. The primary objective is to evaluate changes in ONSD, and the secondary objective is to determine the potential impact of these changes on intracranial pressure.
- Conditions
- Open Heart Surgery, Cardiopulmonary Bypass, Intracranial Pressure, Optic Nerve Sheath Diameter
- Being tested
- Ultrasonography of the Optic Nerve Sheath
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasonography of the Optic Nerve SheathProcedure or surgery
Ultrasonographic measurement of the optic nerve sheath diameter (ONSD) will be performed using a 7.5 MHz linear probe. Measurements will be taken 3 mm behind the globe in both transverse and sagittal planes, three times for each eye, and the average value will be recorded at predefined time points during cardiopulmonary bypass.
| Study group | Role | What they receive |
|---|---|---|
| Study Cohort | Adult patients (18-85 years) undergoing elective open-heart surgery with cardiopulmonary bypass. Optic nerve sheath diameter (ONSD) will be measured by ultrasonography at predefined time points, along with hemodynamic parameters, NIRS values, and arterial blood gas analyses. Receives: Procedure: Ultrasonography of the Optic Nerve Sheath |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Optic Nerve Sheath Diameter (ONSD)
Evaluation of ONSD changes measured by ultrasonography to assess potential alterations in intracranial pressure during cardiopulmonary bypass.
Measured: From tracheal intubation (baseline) until the end of surgery (approximately 4-6 hours); measurements at six predefined time points (post-intubation, CPB initiation, 15 min, 45 min, 15 min after CPB termination, end of surgery).
Secondary outcomes (6)
Mean Arterial Pressure (MAP)
Measurement of mean arterial pressure.
Measured: From induction of anesthesia until the end of surgery, recorded simultaneously with OSD measurements.
Central Venous Pressure (CVP)
Measurement of central venous pressure.
Measured: From induction of anesthesia until the end of surgery, recorded simultaneously with OSD measurements.
Arterial Blood pH
Analysis of arterial blood pH values
Measured: From tracheal intubation (baseline) until the end of surgery (approximately 4-6 hours); measurements at six predefined time points (post-intubation, CPB initiation, 15 min, 45 min, 15 min after CPB termination, end of surgery).
Partial Pressure of Arterial Carbon Dioxide (PaCO₂)
Analysis of partial pressure of arterial carbon dioxide.
Measured: From tracheal intubation (baseline) until the end of surgery (approximately 4-6 hours); measurements at six predefined time points (post-intubation, CPB initiation, 15 min, 45 min, 15 min after CPB termination, end of surgery).
Lactate
Analysis of blood lactate levels.
Measured: From tracheal intubation (baseline) until the end of surgery (approximately 4-6 hours); measurements at six predefined time points (post-intubation, CPB initiation, 15 min, 45 min, 15 min after CPB termination, end of surgery).
partial Pressure of Arterial Oxygen (PaO₂)
Analysis of partial pressure of arterial oxygen.
Measured: From tracheal intubation (baseline) until the end of surgery (approximately 4-6 hours); measurements at six predefined time points (post-intubation, CPB initiation, 15 min, 45 min, 15 min after CPB termination, end of surgery).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2025
- Study start10 Jun 2025
- Primary completion10 Oct 2025
- Study completion25 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Open Heart SurgeryStudies of the same condition, open and under way.
- More trials run by Medipol UniversityThe sponsor's other registered studies.
- 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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medipol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Burak Omur, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07253922
- Sponsor's protocol ID
- Medipol-OSKC-2025
- Status last verified
- Nov 2025
- First submitted
- 22 Aug 2025
- Last updated
- 28 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Omur B, Ciftci B, Karaaslan P. Evaluation of optic nerve sheath diameter in patients undergoing laparoscopic surgery in the Trendelenburg position: a prospective observational study. Ann Saudi Med. 2024 Sep-Oct;44(5):319-328. doi: 10.5144/0256-4947.2024.319. Epub 2024 Oct 3.
PubMed 39368121Writing Group Members; Mozaffarian D, Benjamin EJ, Go AS, Arnett DK, Blaha MJ, Cushman M, Das SR, de Ferranti S, Despres JP, Fullerton HJ, Howard VJ, Huffman MD, Isasi CR, Jimenez MC, Judd SE, Kissela BM, Lichtman JH, Lisabeth LD, Liu S, Mackey RH, Magid DJ, McGuire DK, Mohler ER 3rd, Moy CS, Muntner P, Mussolino ME, Nasir K, Neumar RW, Nichol G, Palaniappan L, Pandey DK, Reeves MJ, Rodriguez CJ, Rosamond W, Sorlie PD, Stein J, Towfighi A, Turan TN, Virani SS, Woo D, Yeh RW, Turner MB; American Heart Association Statistics Committee; Stroke Statistics Subcommittee. Heart Disease and Stroke Statistics-2016 Update: A Report From the American Heart Association. Circulation. 2016 Jan 26;133(4):e38-360. doi: 10.1161/CIR.0000000000000350. Epub 2015 Dec 16. No abstract available.
PubMed 26673558Ismail A, Semien G, Sharma S, Collier SA, Miskolczi SY. Cardiopulmonary Bypass. 2024 Aug 12. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK482190/
PubMed 29489210
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Evaluation of Optic Nerve Sheath Diameter Changes Measured by Ultrasonography During Cardiopulmonary Bypass in Patients Undergoing Open Heart Surgery
- ClinicalTrials.gov ID
- NCT07253922
- Acronym / sponsor ID
- Medipol-OSKC-2025
- Conditions
- Open Heart Surgery, Cardiopulmonary Bypass, Intracranial Pressure, Optic Nerve Sheath Diameter
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Medipol UniversityUniversity, hospital or other
- Study start
- 10 Jun 2025 (actual)
- Primary completion
- 10 Oct 2025 (actual)
- Study completion
- 25 Nov 2025 (actual)
- First posted
- 28 Nov 2025 (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.
During cardiopulmonary bypass (CPB) in open-heart surgery, direct measurement of intracranial pressure is not feasible. Evaluation of the optic nerve sheath diameter (ONSD) by ultrasonography is considered a reliable method for predicting increases in intracranial pressure. This study aims to investigate changes in ONSD in patients undergoing open-heart surgery with CPB.
Detailed description
Several mechanisms during CPB-including inflammatory response, hemodilution, reperfusion injury, hypothermia-rewarming imbalances, and microembolism formation-can lead to increased intracranial pressure and cerebral edema. Ultrasonographic measurement of ONSD provides a noninvasive means of monitoring these changes. In this study, ONSD will be measured at different time points, while hemodynamic parameters, NIRS values, and arterial blood gas analyses will be recorded simultaneously. The primary objective is to evaluate changes in ONSD, and the secondary objective is to determine the potential impact of these changes on intracranial pressure.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Cohort | – | Procedure: Ultrasonography of the Optic Nerve SheathAdult patients (18-85 years) undergoing elective open-heart surgery with cardiopulmonary bypass. Optic nerve sheath diameter (ONSD) will be measured by ultrasonography at predefined time points, along with hemodynamic parameters, NIRS values, and arterial blood gas analyses. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adult patients (18-85 years) undergoing elective open-heart surgery with cardiopulmonary bypass at Istanbul Medipol University Hospital, who meet inclusion criteria and provide written informed consent.
Key inclusion criteria (3 listed)
- Adults aged 18-85 years
- Scheduled for elective open-heart surgery with cardiopulmonary bypass
- Provided written informed consent
Key exclusion criteria (3 listed)
- Ocular or neurological complications related to diabetes
- History of previous eye, brain, or thoracic surgery
- Diagnosis of hydrocephalus, glaucoma, intracranial mass, or stroke
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 |
|---|---|---|
| Ultrasonography of the Optic Nerve SheathUltrasonographic measurement of the optic nerve sheath diameter (ONSD) will be performed using a 7.5 MHz linear probe. Measurements will be taken 3 mm behind the globe in both transverse and sagittal planes, three times for each eye, and the average value will be recorded at predefined time points during cardiopulmonary bypass. | Procedure or surgery | Study Cohort |
Primary outcome
Change in Optic Nerve Sheath Diameter (ONSD)
Time frame: From tracheal intubation (baseline) until the end of surgery (approximately 4-6 hours); measurements at six predefined time points (post-intubation, CPB initiation, 15 min, 45 min, 15 min after CPB termination, end of surgery).
Evaluation of ONSD changes measured by ultrasonography to assess potential alterations in intracranial pressure during cardiopulmonary bypass.
6 secondary outcomes
Mean Arterial Pressure (MAP)
Time frame: From induction of anesthesia until the end of surgery, recorded simultaneously with OSD measurements.
Central Venous Pressure (CVP)
Time frame: From induction of anesthesia until the end of surgery, recorded simultaneously with OSD measurements.
Arterial Blood pH
Time frame: From tracheal intubation (baseline) until the end of surgery (approximately 4-6 hours); measurements at six predefined time points (post-intubation, CPB initiation, 15 min, 45 min, 15 min after CPB termination, end of surgery).
Partial Pressure of Arterial Carbon Dioxide (PaCO₂)
Time frame: From tracheal intubation (baseline) until the end of surgery (approximately 4-6 hours); measurements at six predefined time points (post-intubation, CPB initiation, 15 min, 45 min, 15 min after CPB termination, end of surgery).
Lactate
Time frame: From tracheal intubation (baseline) until the end of surgery (approximately 4-6 hours); measurements at six predefined time points (post-intubation, CPB initiation, 15 min, 45 min, 15 min after CPB termination, end of surgery).
partial Pressure of Arterial Oxygen (PaO₂)
Time frame: From tracheal intubation (baseline) until the end of surgery (approximately 4-6 hours); measurements at six predefined time points (post-intubation, CPB initiation, 15 min, 45 min, 15 min after CPB termination, end of surgery).
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 28 Nov 2025.
- Background: PubMed 39368121Omur B, Ciftci B, Karaaslan P. Evaluation of optic nerve sheath diameter in patients undergoing laparoscopic surgery in the Trendelenburg position: a prospective observational study. Ann Saudi Med. 2024 Sep-Oct;44(5):319-328. doi: 10.5144/0256-4947.2024.319. Epub 2024 Oct 3.
- Background: PubMed 26673558Writing Group Members; Mozaffarian D, Benjamin EJ, Go AS, Arnett DK, Blaha MJ, Cushman M, Das SR, de Ferranti S, Despres JP, Fullerton HJ, Howard VJ, Huffman MD, Isasi CR, Jimenez MC, Judd SE, Kissela BM, Lichtman JH, Lisabeth LD, Liu S, Mackey RH, Magid DJ, McGuire DK, Mohler ER 3rd, Moy CS, Muntner P, Mussolino ME, Nasir K, Neumar RW, Nichol G, Palaniappan L, Pandey DK, Reeves MJ, Rodriguez CJ, Rosamond W, Sorlie PD, Stein J, Towfighi A, Turan TN, Virani SS, Woo D, Yeh RW, Turner MB; American Heart Association Statistics Committee; Stroke Statistics Subcommittee. Heart Disease and Stroke Statistics-2016 Update: A Report From the American Heart Association. Circulation. 2016 Jan 26;133(4):e38-360. doi: 10.1161/CIR.0000000000000350. Epub 2015 Dec 16. No abstract available.
- Background: PubMed 29489210Ismail A, Semien G, Sharma S, Collier SA, Miskolczi SY. Cardiopulmonary Bypass. 2024 Aug 12. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK482190/
- Individual participant dataSharing planned: No
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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 Open Heart Surgery and Cardiopulmonary Bypass, run by Medipol 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 3 inclusion and 3 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 28 Nov 2025. 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?
Change in Optic Nerve Sheath Diameter (ONSD) (time frame: From tracheal intubation (baseline) until the end of surgery (approximately 4-6 hours); measurements at six predefined time points (post-intubation, CPB initiation, 15 min, 45 min, 15 min after CPB termination, end of surgery).). 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 NCT07253922, which also lists 3 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 28 Nov 2025.