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

July 8, 2026 updated by: Jefferson K Hidayat, Indonesia University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study is a single-blind randomized controlled trial evaluating the use of a cooling helmet as an additional neuroprotective strategy during open heart surgery with cardiopulmonary bypass. Postoperative cognitive dysfunction is an important neurologic complication after cardiac surgery and may affect memory, attention, executive function, recovery, independence, and quality of life.

During cardiopulmonary bypass, the brain may be exposed to several potential mechanisms of injury, including reduced cerebral perfusion, microemboli, systemic inflammation, changes in oxygen delivery, and temperature changes during cooling and rewarming. Mild hypothermia has been proposed as a neuroprotective strategy because lower temperature can reduce cerebral metabolic demand, oxygen consumption, excitotoxicity, inflammatory response, free radical production, and neuronal apoptosis.

The cooling helmet used in this study is a non-invasive head-cooling device designed to provide more even and continuous cooling than conventional external ice application. The device consists of water-filled tubing arranged around the head and connected to a pump and cooling box. In the intervention group, cold water is circulated through the helmet during cardiopulmonary bypass. In the control group, room-temperature water is circulated through the same helmet. Participants are blinded to group allocation.

Cognitive function is assessed before surgery and again after surgery using neurocognitive tests that evaluate memory, attention, and executive function. These include the Rey Auditory Verbal Learning Test, Digit Span Forward and Backward, and Trail Making Test A and B. POCD is determined by comparing postoperative neurocognitive performance with baseline performance before surgery.

Intraoperative monitoring includes standard anesthetic monitoring, cerebral regional oxygen saturation monitoring using near-infrared spectroscopy, and temperature monitoring using nasopharyngeal and rectal temperature probes. The study also observes potential side effects related to the cooling helmet, including cold-related skin injury and shivering.

This study is designed to clarify whether localized head cooling with a cooling helmet can reduce postoperative cognitive dysfunction in adults undergoing open heart surgery with cardiopulmonary bypass.

Study Type

Interventional

Enrollment (Actual)

153

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Indonesia
    • DKI Jakarta
      • Jakarta Pusat, DKI Jakarta, Indonesia, 10430
        • Dr. Cipto Mangunkusumo National Central General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cooling Helmet On
Participants assigned to this group wore a cooling helmet during open heart surgery with cardiopulmonary bypass. Cold water was circulated through the helmet as a localized head-cooling intervention.
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.
Other Names:
  • Head Cooling Helmet
  • Local Head Cooling
Sham Comparator: Cooling Helmet Off
Participants assigned to this group wore the same cooling helmet during open heart surgery with cardiopulmonary bypass, but room-temperature water was circulated through the helmet.
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.
Other Names:
  • Sham Cooling Helmet
  • Control Cooling Helmet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Postoperative Cognitive Dysfunction
Time Frame: From 1 day before surgery to postoperative day 7
Incidence of postoperative cognitive dysfunction (POCD), defined as a decline of 20% or more in at least two neurocognitive tests after surgery compared with preoperative baseline. Neurocognitive function was assessed using the Rey Auditory Verbal Learning Test, Digit Span Forward and Backward, and Trail Making Test A and B.
From 1 day before surgery to postoperative day 7

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indonesia University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 30, 2025

Primary Completion (Actual)

May 26, 2026

Study Completion (Actual)

June 11, 2026

Study Registration Dates

First Submitted

July 1, 2026

First Submitted That Met QC Criteria

July 1, 2026

First Posted (Actual)

July 8, 2026

Study Record Updates

Last Update Posted (Actual)

July 9, 2026

Last Update Submitted That Met QC Criteria

July 8, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 25-07-1141

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be shared. Participant data are kept confidential and are accessible only to the research team and ethics committee for verification purposes. Study results may be reported in aggregate form without identifying individual participants.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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