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Completed

NCT Number: NCT05264766

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

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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Key information

Conditions

Heart; Surgery, Heart, Functional Disturbance as Result Confusion Delirium Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cipto Mangunkusumo Central National Hospital

Jakarta Pusat, DKI Jakarta, 10430, Indonesia

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cooling helmet on

Device

Cooling helmet with circulating cold water

Cooling helmet off

Device

Cooling helmet without circulating cold water

Primary outcomes

  1. Neuron-specific enolase

    Time frame: 6 hours post cardiopulmonary bypass off

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

  2. 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

Sponsors and collaborators

Lead sponsor

Indonesia University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Mar 3, 2022
Registry last updated
Mar 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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