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

Indonesia University26 enrolled

Overview

To know the relationship between the use of cooling helmet with the changes of NSE level and postoperative delirium event in open heart surgery

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Heart; Surgery, Heart, Functional Disturbance as Result

Interventions

Cooling helmet onDEVICE

Cooling helmet with circulating cold water

Cooling helmet offDEVICE

Cooling helmet without circulating cold water

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Cipto Mangunkusumo Central National Hospital

Jakarta Pusat, DKI Jakarta, Indonesia

Outcomes

Primary Outcomes

Neuron-specific enolase

Neuronal injury marker. The higher the value, the worse the outcome

Time frame: 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

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

Data from ClinicalTrials.gov

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