Monitoring of Cerebral Oxygenation Using Jugular Oximetry in Comatose Patients After Cardiac Arrest

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Monitoring of Cerebral Oxygenation Using Jugular Oximetry in Comatose Patients After Cardiac Arrest

Conditions
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Cerebral Hypoxic Injury, Cardiac Arrest

Intervention / Treatment
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* Other: BIS Monitor-guided sedation
* Other: Jugular bulb catheter


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age 18 or older successful cardiopulmonary resuscitation persistent coma defined as: no eye opening to voice and inability to follow commands Exclusion Criteria: pre-existing do not resuscitate status severe coexisting systemic disease with a limited life expectancy pregnancy patients who will die within 72 h of the initial cardiac arrest

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Hypoxic brain injury<br>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<br>* 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.<br>Other: Jugular bulb catheter<br>* Jugular bulb catheter will be implanted in the patients enrolled in the study.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 24 months | 
| Serum S100B level | The serum S100B level will be monitored after admission of the patients to ICU | 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 | 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 | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cardiac arrest, jugular venous oximetry, hypoxic brain injury