Clinical Trial

Effect of a Cooling Helmet on Postoperative Cognitive Dysfunction in Adults Undergoing Open-Heart Surgery

Study acronym: HELMET-POCD
Completed
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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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2026-07-01.
Trial Details
NCT Number NCT07689500
Lead Sponsor Indonesia University
Conditions Postoperative Cognitive Complications, Open Heart Surgery
Enrollment 153 participants
Start Date 2025-11-30
Primary Completion 2026-05-26 (estimated)
Study Completion 2026-06-11 (estimated)
Updated on ClinicalTrials.gov 2026-07-09