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Effect of a Cooling Helmet on Postoperative Cognitive Dysfunction in Adults Undergoing Open-Heart Surgery
Sponsor: Indonesia University
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.
Official title: Effectiveness of Cooling Helmet Use on the Incidence of Postoperative Cognitive Dysfunction in Adult Patients Undergoing Open-Heart Surgery: A Single-Blind Randomized Clinical Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
153
Start Date
2025-11-30
Completion Date
2026-06-11
Last Updated
2026-07-09
Healthy Volunteers
No
Interventions
Cooling Helmet With Cold Water Circulation
A non-invasive head-cooling device placed on the participant's head during open heart surgery with cardiopulmonary bypass. The device consists of water-filled tubing connected to a pump and cooling box. In this intervention, cold water was circulated through the helmet to provide localized head cooling during cardiopulmonary bypass.
Cooling Helmet With Room-Temperature Water Circulation
The same non-invasive cooling helmet device was placed on the participant's head during open heart surgery with cardiopulmonary bypass. In this control intervention, room-temperature water was circulated through the helmet instead of cold water.
Locations (1)
Dr. Cipto Mangunkusumo National Central General Hospital
Jakarta Pusat, DKI Jakarta, Indonesia