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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02806778
Enrollment
40
Registered
2016-06-21
Start date
2016-06-30
Completion date
2018-10-31
Last updated
2019-03-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Arrest, Cerebral Hypoxic Injury

Keywords

cardiac arrest, jugular venous oximetry, hypoxic brain injury

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.

Interventions

OTHERBIS 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.

OTHERJugular bulb catheter

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

Sponsors

University Hospital Ostrava
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Serum NSE level24 monthsThe serum NSE level will be monitored after admission of the patient to ICU and 24, 48 and 72 hour after cardiac arrest
Oxygen Saturation of Jugular Venous Bulb24 monthsThe 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 level24 monthsThe serum S100B level will be monitored after admission of the patients to ICU
BIS monitor guided sedation to level 40-6024 monthsBIS 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

MeasureTime frameDescription
Functional status24 monthsFunctional 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

Countries

Czechia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026