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

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.

Study Overview

• Status: Completed
• Conditions: Cardiac Arrest; Cerebral Hypoxic Injury
• Intervention / Treatment: Other: BIS Monitor-guided sedation; Other: Jugular bulb catheter

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 Type: Observational
• Enrollment (Actual): 40

Contacts and Locations

Study Locations

• Czechia
  • Moravian-Silesian Region
    • Ostrava-Poruba, Moravian-Silesian Region, Czechia, 708 52
      • University Hospital Ostrava

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Consecutive out-of-hospital, post-cardiac arrest patients who remain comatose after successful resuscitation, admitted on ICU University Hospital Ostrava will be enrolled into the study.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital Ostrava

Study record dates

Study Major Dates

• Study Start: June 1, 2016
• Primary Completion (Actual): June 1, 2018
• Study Completion (Actual): October 1, 2018

Study Registration Dates

• First Submitted: June 16, 2016
• First Submitted That Met QC Criteria: June 16, 2016
• First Posted (Estimate): June 21, 2016

Study Record Updates

• Last Update Posted (Actual): March 29, 2019
• Last Update Submitted That Met QC Criteria: March 28, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: cardiac arrest; jugular venous oximetry; hypoxic brain injury
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Arrest
• Other Study ID Numbers: FNO-KARIM-4

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Individual participant data will not be made available. The results of the study will be published in an impact factor journal.