Status:
COMPLETED
The Use of Cooling Helmet for Neuroprotection Management in Open Heart Surgery
Lead Sponsor:
Indonesia University
Conditions:
Heart; Surgery, Heart, Functional Disturbance as Result
Eligibility:
All Genders
18+ years
Phase:
NA
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. ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2021
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT05264766
Start Date
October 1 2021
End Date
December 31 2021
Last Update
March 3 2022
Active Locations (1)
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1
Cipto Mangunkusumo Central National Hospital
Jakarta Pusat, DKI Jakarta, Indonesia, 10430