Heart; Surgery, Heart, Functional Disturbance as ResultNCT05264766
The Use of Cooling Helmet for Neuroprotection Management in Open Heart Surgery
A study testing Cooling helmet on and Cooling helmet off in people with Heart; Surgery, Heart, Functional Disturbance as Result, run by Universitas Indonesia at 1 site in Indonesia.
Trial summary
To know the relationship between the use of cooling helmet with the changes of NSE level and postoperative delirium event in open heart surgery Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart; Surgery, Heart, Functional Disturbance as Result
- What is being tested?
- Cooling helmet on and Cooling helmet off
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Oct 2021to 31 Dec 2021
- 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
- Patient undergoing their first open heart surgery using cardiopulmonary bypass
- Age ≥18 year-old
- Patient with American Society of Anesthesiologists (ASA) III
- Patient with Glasgow Coma Scale (GCS) 15, fully aware and oriented
- Patient fluent in Indonesia
Who cannot join
- Patients did not give consent to participate in the study
- Patients with central nervous system disease (stroke, intracranial tumor)
- Patients with psychiatric problem (schizophrenia, depression)
- Patients with cognitive problem
- Blind and deaf patient
- Patient on psychotrophic or narcotics medication
Show all 10Show fewer
- Drop out criteria
- Surgery without cardiopulmonary bypass
- Patient demise after surgery
- Patients decided to refrain from the study
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Cipto Mangunkusumo Central National Hospital
Jakarta Pusat, DKI Jakarta, 10430
About this study
Official title: The Use of Cooling Helmet for Neuroprotection Management in Patient Undergoing Open Heart Surgery: an Evaluation of Postoperative Neuron-specific Enolase (NSE) and Delirium
To know the relationship between the use of cooling helmet with the changes of NSE level and postoperative delirium event in open heart surgery
Read the detailed description
Subjects were assigned into two groups after giving consent to participate in the study using random allocation, 13 subjects per group. Blood sample from CVC were obtained to assess NSE preoperative. After induction, cooling helmet with circulating cold water were placed on patients group A and without circulating cold water on group B. Blood samples were obtain again 6 hours after cardiopulmonary bypass off to assess NSE postoperative. Delirium was assessed using Confusion Assessment Method - Intensive Care Unit (CAM-ICU)
- Being tested
- Cooling helmet on, Cooling helmet off
- Keywords
- cooling helmet, neuron specific enolase, delirium, open heart surgery
- Medical subject headings
- Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cooling helmet onDevice
Cooling helmet with circulating cold water
Cooling helmet offDevice
Cooling helmet without circulating cold water
| Study group | Role | What they receive |
|---|---|---|
| Cooling helmet on | Experimental | Cooling helmet on means there was circulating cold water inside the helmet, put after induction during cardiopulmonary bypass on Receives: Device: Cooling helmet on |
| Cooling helmet off | Active comparator | Cooling helmet on means there was no circulating cold water inside the helmet, put after induction during cardiopulmonary bypass on Receives: Device: Cooling helmet off |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neuron-specific enolase
Neuronal injury marker. The higher the value, the worse the outcome
Measured: 6 hours post cardiopulmonary bypass off
Confusion Assessment Method - Intensive Care Unit (CAM-ICU)
Tools to assess delirium. The higher the errors, the worse the outcome
Measured: Changes of CAM-ICU from 12 hours to 24 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2022
- Study start1 Oct 2021
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart; Surgery, Heart, Functional Disturbance as ResultStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamad Prakoso Adji, Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05264766
- Sponsor's protocol ID
- IndonesiaUAnes333
- Status last verified
- Mar 2022
- First submitted
- 18 Feb 2022
- Last updated
- 3 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Cooling Helmet for Neuroprotection Management in Patient Undergoing Open Heart Surgery: an Evaluation of Postoperative Neuron-specific Enolase (NSE) and Delirium
- ClinicalTrials.gov ID
- NCT05264766
- Acronym / sponsor ID
- IndonesiaUAnes333
- Keywords
- cooling helmet, neuron specific enolase, delirium, open heart surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 3 Mar 2022 (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.
To know the relationship between the use of cooling helmet with the changes of NSE level and postoperative delirium event in open heart surgery
Detailed description
Subjects were assigned into two groups after giving consent to participate in the study using random allocation, 13 subjects per group. Blood sample from CVC were obtained to assess NSE preoperative. After induction, cooling helmet with circulating cold water were placed on patients group A and without circulating cold water on group B. Blood samples were obtain again 6 hours after cardiopulmonary bypass off to assess NSE postoperative. Delirium was assessed using Confusion Assessment Method - Intensive Care Unit (CAM-ICU)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cooling helmet on | Experimental | Device: Cooling helmet onCooling helmet on means there was circulating cold water inside the helmet, put after induction during cardiopulmonary bypass on |
| Cooling helmet off | Active comparator | Device: Cooling helmet offCooling helmet on means there was no circulating cold water inside the helmet, put after induction during cardiopulmonary bypass on |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient undergoing their first open heart surgery using cardiopulmonary bypass
- Age ≥18 year-old
- Patient with American Society of Anesthesiologists (ASA) III
- Patient with Glasgow Coma Scale (GCS) 15, fully aware and oriented
- Patient fluent in Indonesia
Key exclusion criteria (10 listed)
- Patients did not give consent to participate in the study
- Patients with central nervous system disease (stroke, intracranial tumor)
- Patients with psychiatric problem (schizophrenia, depression)
- Patients with cognitive problem
- Blind and deaf patient
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 onCooling helmet with circulating cold water | Device | Cooling helmet on |
| Cooling helmet offCooling helmet without circulating cold water | Device | Cooling helmet off |
Primary outcome
Neuron-specific enolase
Time frame: 6 hours post cardiopulmonary bypass off
Neuronal injury marker. The higher the value, the worse the outcome
Confusion Assessment Method - Intensive Care Unit (CAM-ICU)
Time frame: Changes of CAM-ICU from 12 hours to 24 hours postoperative
Tools to assess delirium. The higher the errors, the worse the outcome
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 3 Mar 2022.
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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 on and Cooling helmet off in people with Heart; Surgery, Heart, Functional Disturbance as Result, 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 10 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 3 Mar 2022. 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. 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?
Neuron-specific enolase (time frame: 6 hours post cardiopulmonary bypass off). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Mar 2022.