Postoperative Cognitive ComplicationsHELMET-POCDNCT07689500
Effect of a Cooling Helmet on Postoperative Cognitive Dysfunction in Adults Undergoing Open-Heart Surgery
A study testing Cooling Helmet With Cold Water Circulation and Cooling Helmet With Room-Temperature Water Circulation in people with Postoperative Cognitive Complications and Open Heart Surgery, run by Universitas Indonesia at 1 site in Indonesia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Cognitive Complications, Open Heart Surgery
- What is being tested?
- Cooling Helmet With Cold Water Circulation and Cooling Helmet With Room-Temperature Water Circulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 153 participants
- Where
- 1 siteIndonesia
- Study dates
- 30 Nov 2025to 11 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Dr. Cipto Mangunkusumo National Central General Hospital
Jakarta Pusat, DKI Jakarta, 10430
About this study
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
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.
Read the 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.
- Being tested
- Cooling Helmet With Cold Water Circulation, Cooling Helmet With Room-Temperature Water Circulation
- Keywords
- Postoperative Cognitive Dysfunction, Cooling Helmet, Open Heart Surgery, Cardiopulmonary Bypass, Hypothermia, Neuroprotection, Head Cooling, Cerebral Oximetry, Near-Infrared Spectroscopy
- Medical subject headings
- Postoperative Cognitive Complications, Hypothermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cooling Helmet With Cold Water CirculationDevice
Also called Head Cooling Helmet, Local Head Cooling
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 CirculationDevice
Also called Sham Cooling Helmet, Control Cooling Helmet
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Cooling Helmet With Room-Temperature Water Circulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From 1 day before surgery to postoperative day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2026
- Study start30 Nov 2025
- Primary completion26 May 2026
- Study completion11 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Postoperative Cognitive ComplicationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 153 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jefferson K Hidayat, Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07689500
- Sponsor's protocol ID
- 25-07-1141
- Acronym
- HELMET-POCD
- Status last verified
- Jul 2026
- First submitted
- 1 Jul 2026
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
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.
PubMed 34886474Soenarto 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.
PubMed 33785934Sirvinskas 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.
PubMed 23878011Soenarto 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.
PubMed 30719417
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07689500
- Acronym / sponsor ID
- HELMET-POCD / 25-07-1141
- Keywords
- Postoperative Cognitive Dysfunction, Cooling Helmet, Open Heart Surgery, Cardiopulmonary Bypass, Hypothermia, Neuroprotection, Head Cooling, Cerebral Oximetry
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 153 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 30 Nov 2025 (actual)
- Primary completion
- 26 May 2026 (actual)
- Study completion
- 11 Jun 2026 (actual)
- First posted
- 8 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Cooling Helmet On | Experimental | Device: Cooling Helmet With Cold Water CirculationParticipants 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. |
| Cooling Helmet Off | Sham comparator | Device: Cooling Helmet With Room-Temperature Water CirculationParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cooling Helmet With Cold Water CirculationAlso: Head Cooling Helmet, Local Head CoolingA 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 On |
| Cooling Helmet With Room-Temperature Water CirculationAlso: Sham Cooling Helmet, Control Cooling HelmetThe 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. | Device | Cooling Helmet Off |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2026.
- BackgroundAdji 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: PubMed 34886474Motshabi-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.
- Background: PubMed 33785934Soenarto 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.
- Background: PubMed 23878011Sirvinskas 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.
- Background: PubMed 30719417Soenarto 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.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cooling Helmet With Cold Water Circulation and Cooling Helmet With Room-Temperature Water Circulation in people with Postoperative Cognitive Complications and Open Heart Surgery, run by Universitas Indonesia at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Postoperative Cognitive Dysfunction (time frame: From 1 day before surgery to postoperative day 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07689500, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2026.