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

NCT07689500 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 153

Last updated 2026-07-09

No results posted yet for this study

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.

Conditions

  • Postoperative Cognitive Complications
  • Open Heart Surgery

Interventions

DEVICE

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.

DEVICE

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.

Sponsors & Collaborators

  • Indonesia University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-30
Primary Completion
2026-05-26
Completion
2026-06-11

Countries

  • Indonesia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07689500 on ClinicalTrials.gov