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

University of Indonesia (UI)

Status: Completed

Conditions: Heart; Surgery, Heart, Functional Disturbance as Result

Treatments: Device: Cooling helmet off; Device: Cooling helmet on

Study type: Interventional

Funder types: Other

Identifiers

NCT05264766

IndonesiaUAnes333

Details and patient eligibility

About

To know the relationship between the use of cooling helmet with the changes of NSE level and postoperative delirium event in open heart surgery

Full 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)

Enrollment: 26 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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26 participants in 2 patient groups

Cooling helmet on

Experimental group

Description:

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

Treatment:

Device: Cooling helmet on

Cooling helmet off

Active Comparator group

Description:

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

Treatment:

Device: Cooling helmet off