Heart; Surgery, Heart, Functional Disturbance as Result
Conditions
Keywords
cooling helmet, neuron specific enolase, delirium, open heart surgery
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)
Interventions
DEVICECooling helmet on
Cooling helmet with circulating cold water
DEVICECooling helmet off
Cooling helmet without circulating cold water
Sponsors
Indonesia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Indonesia
Outcome results
None listed