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Completed
NCT07689500
Effect of a Cooling Helmet on Postoperative Cognitive Dysfunction in Adults Undergoing Open-Heart Surgery
Conditions: Postoperative Cognitive Complications, Open Heart Surgery
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 153
Sponsor: Indonesia University
Location: Dr. Cipto Mangunkusumo National Central General Hospital Jakarta Pusat DKI Jakarta
Summary
Postoperative cognitive dysfunction, or POCD, is a decline in thinking, memory, attention, or executive function that may occur after surgery and anesthesia. Patients undergoing open heart surgery with cardiopulmonary bypass may have a higher risk of POCD because of changes in blood flow, inflammation, microemboli, and changes in brain oxygen supply during surgery.
Cooling the head during open heart surgery may help protect the brain by reducing brain metabolism, oxygen demand, inflammation, and cellular injury. A cooling helmet is a non-invasive device placed on the patient's head during surgery. In this study, the cooling helmet is used to circulate cold water around the scalp during cardiopulmonary bypass.
The purpose of this study is to determine whether the use of a cooling helmet reduces the incidence of POCD in adult patients undergoing open heart surgery with cardiopulmonary bypass. The main question is whether patients who receive head cooling with a cooling helmet have a lower rate of POCD compared with patients who wear the same helmet with room-temperature water circulation.
Eligibility Criteria
Inclusion Criteria:
* Scheduled to undergo open heart surgery using cardiopulmonary bypass.
* Age older than 18 years.
* American Society of Anesthesiologists (ASA) physical status III or IV.
* Fully conscious with Glasgow Coma Scale score of 15.
* Able to communicate in Indonesian.
Exclusion Criteria:
* Refusal to participate in the study.
* History of central nervous system disorder, such as stroke or intracranial tumor.
* History of psychiatric disorder.
* Severe cognitive impairment.
* Use of psychotropic or narcotic drugs.
* Blindness or hearing impairment.
* Uncooperative patient.
Source: ClinicalTrials.gov (NCT07689500). StuddyBuddy aggregates publicly available trial information.