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Completed

NCT Number: NCT02806778

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Ostrava

Ostrava-Poruba, Moravian-Silesian Region, 708 52, Czechia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BIS Monitor-guided sedation

Other

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

Other

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

Primary outcomes

  1. Oxygen Saturation of Jugular Venous Bulb

    Time frame: 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

  2. Serum S100B level

    Time frame: 24 months

    The serum S100B level will be monitored after admission of the patients to ICU

  3. Serum NSE level

    Time frame: 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

  4. BIS monitor guided sedation to level 40-60

    Time frame: 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 outcomes

  1. Functional status

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University Hospital Ostrava

Other

Registry information

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Jun 21, 2016
Registry last updated
Mar 29, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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