NCT02806778

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 40 (actual)
• Sponsor: University Hospital Ostrava · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
OTHER	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.
OTHER	Jugular bulb catheter	Jugular bulb catheter will be implanted in the patients enrolled in the study.

Timeline

• Start date: 2016-06-01
• Primary completion: 2018-06-01
• Completion: 2018-10-01
• First posted: 2016-06-21
• Last updated: 2019-03-29

Locations

1 site across 1 country: Czechia