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Evaluation of Optic Nerve Sheath Diameter Changes During Cardiopulmonary Bypass in Open Heart Surgery

M

Medipol University

Status

Completed

Conditions

Optic Nerve Sheath Diameter
Open Heart Surgery
Intracranial Pressure
Cardiopulmonary Bypass

Treatments

Procedure: Ultrasonography of the Optic Nerve Sheath

Study type

Observational

Funder types

Other

Identifiers

NCT07253922
Medipol-OSKC-2025

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Adults aged 18-85 years
  • Scheduled for elective open-heart surgery with cardiopulmonary bypass
  • Provided written informed consent

Exclusion criteria

  • Ocular or neurological complications related to diabetes
  • History of previous eye, brain, or thoracic surgery
  • Diagnosis of hydrocephalus, glaucoma, intracranial mass, or stroke

Trial design

40 participants in 1 patient group

Study Cohort
Description:
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.
Treatment:
Procedure: Ultrasonography of the Optic Nerve Sheath

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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