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

March 2, 2022 updated by: Mohamad Prakoso Adji, Indonesia University

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

26

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Indonesia
    • DKI Jakarta
      • Jakarta Pusat, DKI Jakarta, Indonesia, 10430
        • Cipto Mangunkusumo Central National Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neuron-specific enolase
Time Frame: 6 hours post cardiopulmonary bypass off
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)
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
Changes of CAM-ICU from 12 hours to 24 hours postoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indonesia University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2021

Primary Completion (Actual)

December 31, 2021

Study Completion (Actual)

December 31, 2021

Study Registration Dates

First Submitted

February 18, 2022

First Submitted That Met QC Criteria

March 2, 2022

First Posted (Actual)

March 3, 2022

Study Record Updates

Last Update Posted (Actual)

March 3, 2022

Last Update Submitted That Met QC Criteria

March 2, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • IndonesiaUAnes333

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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