CompletedNot Applicable

The Use of Cooling Helmet for Neuroprotection Management in Open Heart Surgery

Indonesia26 participantsStarted 2021-10-01

Plain-language 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

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Exclusion Criteria: * 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 Drop out criteria * Surgery without cardiopulmonary bypass * Patient demise after surgery * Patients decided to refrain from the study

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Neuron-specific enolase

Timeframe: 6 hours post cardiopulmonary bypass off

Confusion Assessment Method - Intensive Care Unit (CAM-ICU)

Timeframe: Changes of CAM-ICU from 12 hours to 24 hours postoperative

Trial details

NCT IDNCT05264766

SponsorIndonesia University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-12-31

View on ClinicalTrials.gov More Heart; Surgery, Heart, Functional Disturbance as Result trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.