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

Study Overview
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Brief Summary
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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
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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)

Official Title
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The Use of Cooling Helmet for Neuroprotection Management in Patient Undergoing Open Heart Surgery: an Evaluation of Postoperative Neuron-specific Enolase (NSE) and Delirium

Conditions
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Heart; Surgery, Heart, Functional Disturbance as Result

Intervention / Treatment
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* Device: Cooling helmet on
* Device: Cooling helmet off


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cooling helmet on<br>Cooling helmet on means there was circulating cold water inside the helmet, put after induction during cardiopulmonary bypass on | Device: Cooling helmet on<br>* Cooling helmet with circulating cold water<br>|
| Active Comparator: Cooling helmet off<br>Cooling helmet on means there was no circulating cold water inside the helmet, put after induction during cardiopulmonary bypass on | Device: Cooling helmet off<br>* Cooling helmet without circulating cold water<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neuron-specific enolase | Neuronal injury marker. The higher the value, the worse the outcome | 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 | Changes of CAM-ICU from 12 hours to 24 hours postoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cooling helmet, neuron specific enolase, delirium, open heart surgery