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

Cardiac Arrest Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02806778
• Other study ID #: FNO-KARIM-4
• Status: Completed
• Start date: June 2016
• Est. completion date: October 2018

Study information

• Verified date: March 2019
• Source: University Hospital Ostrava
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: October 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Arrest
• Cerebral Hypoxic Injury
• Heart Arrest

Intervention

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

Locations

Country	Name	City	State
Czechia	University Hospital Ostrava	Ostrava-Poruba	Moravian-Silesian Region

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Ostrava

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Serum S100B level	The serum S100B level will be monitored after admission of the patients to ICU	24 months
Primary	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
Primary	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	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