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

Not Applicable

Completed

• Conditions: Heart; Surgery, Heart, Functional Disturbance as Result
• Interventions: Device: Cooling helmet on; Device: Cooling helmet off

• Registration Number: NCT05264766
• Lead Sponsor: Indonesia University

Brief Summary

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

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 Timeline

• Study Start: 2021-10-01
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31
• Study First Submitted: 2022-02-18
• Status Verified: 2022-03
• Study First Submitted QC: 2022-03-02
• Last Update Submitted: 2022-03-02
• Study First Posted: 2022-03-03
• Last Update Posted: 2022-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Neuron-specific enolase	6 hours post cardiopulmonary bypass off	Neuronal injury marker. The higher the value, the worse the outcome
Confusion Assessment Method - Intensive Care Unit (CAM-ICU)	Changes of CAM-ICU from 12 hours to 24 hours postoperative	Tools to assess delirium. The higher the errors, the worse the outcome

Trial Locations

Locations (1)

Cipto Mangunkusumo Central National Hospital; 🇮🇩 Jakarta Pusat, DKI Jakarta, Indonesia