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

NCT07689500 | Completed

• 1 other identifier: 25-07-1141
• Study Type: interventional
• Target: 153
• Locations: 1 country
• Sites: 1

Brief 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

Open Heart Surgery; Postoperative Cognitive Complications

Keywords

Postoperative Cognitive Dysfunction; Cooling Helmet; Open Heart Surgery; Cardiopulmonary Bypass; Hypothermia; Neuroprotection; Head Cooling; Cerebral Oximetry; Near-Infrared Spectroscopy

Outcome Measures

Primary Outcomes (1)

• Incidence of Postoperative Cognitive Dysfunction

  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

Study Arms (2)

Cooling Helmet On

EXPERIMENTAL

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

Cooling Helmet Off

SHAM COMPARATOR

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

Interventions

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.

Also known as: Head Cooling Helmet, Local Head Cooling

Cooling Helmet On

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.

Also known as: Sham Cooling Helmet, Control Cooling Helmet

Cooling Helmet Off

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Indonesia University: lead

Study Sites (1)

Dr. Cipto Mangunkusumo National Central General Hospital

Jakarta Pusat, DKI Jakarta, 10430, Indonesia

Location

Related Publications (5)

• Adji MP, Hidayat JK, Heriwardito A. Neuroprotection role of cooling helmet on neuron specific enolase (NSE) and post-surgery delirium levels in open heart surgery patients: a randomized controlled trial. Anaesth Pain Intensive Care. 2022;26(5):588-594. doi:10.35975/apic.v26i5.1985.

  BACKGROUND

• Motshabi-Chakane P, Mogane P, Moutlana J, Leballo-Mothibi G, Dingezweni S, Mpanya D, Tsabedze N. Contemporary Neuroprotection Strategies during Cardiac Surgery: State of the Art Review. Int J Environ Res Public Health. 2021 Dec 3;18(23):12747. doi: 10.3390/ijerph182312747.

  PMID: 34886474 BACKGROUND

• Soenarto RF, Hidayat JK, Eureka O, Auerkari AN. Can Near-Infrared Spectroscopy (NIRS) monitoring prevent post-operative cognitive dysfunction following open- heart surgery? J Pak Med Assoc. 2021 Feb;71(Suppl 2)(2):S10-S13.

  PMID: 33785934 BACKGROUND

• Sirvinskas E, Usas E, Mankute A, Raliene L, Jakuska P, Lenkutis T, Benetis R. Effects of intraoperative external head cooling on short-term cognitive function in patients after coronary artery bypass graft surgery. Perfusion. 2014 Mar;29(2):124-9. doi: 10.1177/0267659113497074. Epub 2013 Jul 22.

  PMID: 23878011 BACKGROUND

• Soenarto RF, Mansjoer A, Amir N, Aprianti M, Perdana A. Cardiopulmonary Bypass Alone Does Not Cause Postoperative Cognitive Dysfunction Following Open Heart Surgery. Anesth Pain Med. 2018 Dec 3;8(6):e83610. doi: 10.5812/aapm.83610. eCollection 2018 Dec.

  PMID: 30719417 BACKGROUND

MeSH Terms

Conditions

Postoperative Cognitive Complications; Hypothermia

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cognitive Dysfunction; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Body Temperature Changes; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants were blinded to group allocation. Both groups wore the same cooling helmet during surgery; however, the intervention group received cold water circulation, while the control group received room-temperature water circulation.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants were randomized into two parallel groups. Both groups wore a cooling helmet during open heart surgery with cardiopulmonary bypass. In the intervention group, cold water was circulated through the helmet. In the control group, room-temperature water was circulated through the helmet.

Study Record Dates

• First Submitted: July 1, 2026
• First Posted: July 8, 2026
• Study Start: November 30, 2025
• Primary Completion: May 26, 2026
• Study Completion: June 11, 2026
• Last Updated: July 9, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)