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

Completed

• Conditions: Cardiac Arrest; Cerebral Hypoxic Injury
• Interventions: Other: BIS Monitor-guided sedation; Other: Jugular bulb catheter

• Registration Number: NCT02806778
• Lead Sponsor: University Hospital Ostrava

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.

Study Timeline

• Study Start: 2016-06
• Study First Submitted: 2016-06-16
• Study First Submitted QC: 2016-06-16
• Study First Posted: 2016-06-21
• Primary Completion: 2018-06
• Study Completion: 2018-10
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-28
• Last Update Posted: 2019-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Hypoxic brain injury	Jugular bulb catheter	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.
Hypoxic brain injury	BIS Monitor-guided sedation	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.

Primary Outcome Measures

Name	Time	Method
Oxygen Saturation of Jugular Venous Bulb	24 months	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
Serum S100B level	24 months	The serum S100B level will be monitored after admission of the patients to ICU
Serum NSE level	24 months	The serum NSE level will be monitored after admission of the patient to ICU and 24, 48 and 72 hour after cardiac arrest
BIS monitor guided sedation to level 40-60	24 months	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

Secondary Outcome Measures

Name	Time	Method
Functional status	24 months	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

Trial Locations

Locations (1)

University Hospital Ostrava; 🇨🇿 Ostrava-Poruba, Moravian-Silesian Region, Czechia