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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ultrasonography of the Optic Nerve Sheath | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Optic Nerve Sheath Diameter (ONSD) | Evaluation of ONSD changes measured by ultrasonography to assess potential alterations in intracranial pressure during cardiopulmonary bypass. | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Arterial Pressure (MAP) | Measurement of mean arterial pressure. | From induction of anesthesia until the end of surgery, recorded simultaneously with OSD measurements. |
| Central Venous Pressure (CVP) |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medipol University | Istanbul | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39368121 | Background | 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. | |
| 26673558 | Background | Writing 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. |
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|
Measurement of central venous pressure.
| From induction of anesthesia until the end of surgery, recorded simultaneously with OSD measurements. |
| Arterial Blood pH | Analysis of arterial blood pH values | 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. | 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. | 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. | 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). |
| 29489210 | Background | Ismail 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/ |