An observational study in Cerebral Hypoxic Injury and Cardiac Arrest, sponsored by University Hospital Ostrava. Completed at 1 site in Czechia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-03-29.
Sponsored by University Hospital Ostrava · Observational
The use of protective ventilation (to maintain normoxia and normocapnia), optimise haemodynamics, diagnose/treat seizures, therapeutic hypotermia etc is recommended for ICU management of patients who have had cardiac arrest and remain in coma after return of spontaneous circulation according to the latest International Guidelines. These actions essentially aim to limit secondary brain injury but despite all therapeutic effort, the cerebral oxygenation may remain inadequate and there is no validated method to avoid such a state in real time.
The use of protective ventilation (to maintain normoxia and normocapnia), optimize hemodynamics, diagnose/treat seizures, therapeutic hypothermia etc is recommended for ICU management of patients who have had cardiac arrest and remain in a coma after the return of spontaneous circulation according to the latest International Guidelines. These actions essentially aim to limit secondary brain injury but despite all therapeutic effort, the cerebral oxygenation may remain inadequate and there is no validated method to avoid such a state in real time.
The objective of this study is to assess the relationship between jugular venous oximetry and neurological outcome of comatose patients after cardiac arrest, evaluated as per the Cerebral Performance Category scale (CPC). Further, the aim is to clarify relations between biomarkers protein S100B, neuron-specific enolase (NSE) and parameters of jugular oximetry for prognostication. An anticipated total of sixty patients will be enrolled in this non-randomised, single-group, double-blind study.
In the course of the study, the authors have decided to stop using BIS monitoring for sedation management. Reason for this decision was very limited reliability of this technique in unparalyzed patients on ICU (muscle artifacts). New aim of sedation was Richmond Agitation Sedation Scale (RASS) -4 or -5, with avoiding shivering and clinically manifested seizures.
966 studies on the registry are indexed under Heart Arrest; 227 are open to participants now.
This study's enrollment of 40 is below the median of 200 across 383 observational studies indexed under Heart Arrest.
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Consecutive out-of-hospital, post-cardiac arrest patients who remain comatose after successful resuscitation, admitted on ICU University Hospital Ostrava will be enrolled into the study.
Exclusion Criteria:
Consecutive out-of-hospital, post-cardiac arrest patients who remain comatose after successful resuscitation, admitted on ICU of University Hospital Ostrava. The patients will undergo BIS monitor-guided sedation and jugular bulb catheterisation.
Other: BIS Monitor-guided sedation · Other: Jugular bulb catheter
The patients enrolled in the study will undergo BIS Monitor-guided sedation. Standard BIS Monitor will be used for the procedure to monitor the depth of sedation.
Jugular bulb catheter will be implanted in the patients enrolled in the study.
Oxygen Saturation of Jugular Venous Bulb
The saturation of oxygen will be monitored after admission to ICU and every 6 hours for the total period of 72 hour after cardiac arrest
Time frame: 24 months
Serum S100B level
The serum S100B level will be monitored after admission of the patients to ICU
Time frame: 24 months
Serum NSE level
The serum NSE level will be monitored after admission of the patient to ICU and 24, 48 and 72 hour after cardiac arrest
Time frame: 24 months
BIS monitor guided sedation to level 40-60
BIS monitor-guided sedation with the aim of achieving the level of 40-60 will be maintained for 36 hour after admission of the patients to ICU
Time frame: 24 months
Functional status
Functional status defined with using cerebral performance category (CPC) classification will be assessed at time of discharge from the hospital and at 3 months after cardiac arrest
Time frame: 24 months
Plan to share: No — Individual participant data will not be made available. The results of the study will be published in an impact factor journal.
No publications or documents are linked to this record.
This study is completed, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.
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University Hospital Ostrava