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

Heart; Surgery, Heart, Functional Disturbance as Result Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05264766
• Other study ID #: IndonesiaUAnes333
• Status: Completed
• Phase: N/A
• Start date: October 1, 2021
• Est. completion date: December 31, 2021

Study information

• Verified date: March 2022
• Source: Indonesia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart; Surgery, Heart, Functional Disturbance as Result

Intervention

Device:
• Cooling helmet on
Cooling helmet with circulating cold water
• Cooling helmet off
Cooling helmet without circulating cold water

Locations

Country	Name	City	State
Indonesia	Cipto Mangunkusumo Central National Hospital	Jakarta Pusat	DKI Jakarta

Sponsors (1)

Lead Sponsor	Collaborator
Indonesia University

Country where clinical trial is conducted

Indonesia, 

Outcome

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