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Completed

NCT Number: NCT07689500

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dr. Cipto Mangunkusumo National Central General Hospital

Jakarta Pusat, DKI Jakarta, 10430, Indonesia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cooling Helmet With Cold Water Circulation

Device

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

Cooling Helmet With Room-Temperature Water Circulation

Device

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

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Indonesia University

Other

Registry information

Official study 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

Acronym: HELMET-POCD

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 8, 2026
Registry last updated
Jul 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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