The Use of Cooling Helmet for Neuroprotection Management in Open Heart Surgery
1 other identifier
interventional
26
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2021
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2021
CompletedFirst Submitted
Initial submission to the registry
February 18, 2022
CompletedFirst Posted
Study publicly available on registry
March 3, 2022
CompletedMarch 3, 2022
March 1, 2022
3 months
February 18, 2022
March 2, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Neuron-specific enolase
Neuronal injury marker. The higher the value, the worse the outcome
6 hours post cardiopulmonary bypass off
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
Study Arms (2)
Cooling helmet on
EXPERIMENTALCooling helmet on means there was circulating cold water inside the helmet, put after induction during cardiopulmonary bypass on
Cooling helmet off
ACTIVE COMPARATORCooling helmet on means there was no circulating cold water inside the helmet, put after induction during cardiopulmonary bypass on
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cipto Mangunkusumo Central National Hospital
Jakarta Pusat, DKI Jakarta, 10430, Indonesia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
February 18, 2022
First Posted
March 3, 2022
Study Start
October 1, 2021
Primary Completion
December 31, 2021
Study Completion
December 31, 2021
Last Updated
March 3, 2022
Record last verified: 2022-03