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

NCT ID: NCT02806778

Last Updated: 2019-03-29

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 40 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-06-30
• Study Completion Date: 2018-10-31

Brief Summary

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

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.

Conditions

Cerebral Hypoxic Injury; Cardiac Arrest

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

Hypoxic brain injury

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.

BIS Monitor-guided sedation

Intervention Type: OTHER

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

Intervention Type: OTHER

Jugular bulb catheter will be implanted in the patients enrolled in the study.

Interventions

BIS Monitor-guided sedation

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.

Intervention Type: OTHER

Jugular bulb catheter

Jugular bulb catheter will be implanted in the patients enrolled in the study.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital Ostrava

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University Hospital Ostrava

Ostrava-Poruba, Moravian-Silesian Region, Czechia

Countries

Czechia

Other Identifiers

FNO-KARIM-4

Identifier Type: -

Identifier Source: org_study_id