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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-01

Study Completion Date

2021-12-31

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

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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)

Conditions

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Heart; Surgery, Heart, Functional Disturbance as Result

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Cooling helmet on

Cooling helmet on means there was circulating cold water inside the helmet, put after induction during cardiopulmonary bypass on

Group Type EXPERIMENTAL

Cooling helmet on

Intervention Type DEVICE

Cooling helmet with circulating cold water

Cooling helmet off

Cooling helmet on means there was no circulating cold water inside the helmet, put after induction during cardiopulmonary bypass on

Group Type ACTIVE_COMPARATOR

Cooling helmet off

Intervention Type DEVICE

Cooling helmet without circulating cold water

Interventions

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Cooling helmet on

Cooling helmet with circulating cold water

Intervention Type DEVICE

Cooling helmet off

Cooling helmet without circulating cold water

Intervention Type DEVICE

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No