Меню
Идёт набор NCT06601842

Monitoring and Optimization of Cerebral Perfusion Pressure in Post-cardiac Arrest Patients: a Pilot Study

Без фазы С лечением Cardiac Arrest

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: ICP monitoring.
Кому может быть актуально
Состояния в реестре: Cardiac Arrest. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Тайвань
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Обзор

The goal of this study is to establish the ICP and CPP monitoring process and analyze the results in post-arrest patients, to validate the correlation between direct and non-invasive ICP monitoring indicators, to establish a protocol of management of elevated ICP and insufficient CPP in post-arrest care, to establish a protocol for personalizing CPP and MAP optimization, and to analyze its impact on neuroprognosis. Participants will receive ICP monitoring within 12 hours post-ROSC if meet all inclusion and exclusion criteria.

Подробное описание

Post-resuscitation care after cardiac arrest is an important emergency and critical care issue. The post-arrest care after the return of spontaneous circulation has also been incorporated into the chain of survival and resuscitation guidelines. After the regain of spontaneous circulation, cardiac arrest patients will face the challenges of post-arrest syndrome, which includes post-anoxic brain injury, myocardial dysfunction, systemic ischemia-reperfusion, and persistent precipitating causes. The hypoxic brain injury will impair the autoregulation of cerebral blood vessels, thereby affecting the adjustment of intracranial pressure (ICP) and causing cerebral edema. High-quality post-arrest care including targeted temperature management, optimization of hemodynamics and respiratory care, control of blood sugar, monitoring and treatment of epilepsy, etc. The goal is to achieve neuroprotective effects and improve patient outcomes.

The modalities that currently have more evidence for neurocritical care and neuroprognosis include electroencephalogram (EEG) monitoring, pupillary light reflex, brain imaging such as computed tomography (CT) and magnetic resonance imaging (MRI), somatosensory evoked potentials (SSEP), and serum biomarkers such as neuron-specific enolase (NSE), etc. Direct ICP monitoring is not routinely used in cardiac arrest patients due to a lack of clinical experience and concurrent use of antiplatelet medications or anticoagulants. The application of ICP monitoring in neurocritical care can be based on the experience of traumatic brain injury. ICP monitoring can facilitate early detection, determination of treatment strategies, and prediction of outcomes. Cerebral perfusion pressure (CPP) can also be obtained by ICP monitoring. Current head injury treatment guidelines recommend maintaining CPP at around 60-70 mmHg. However, there are no current recommendations for CPP standards for post-arrest patients. In recent years, there have been studies on the utilization of the pressure reactivity index to identify the optimized CPP in patients with traumatic brain injury, but not yet applicated in post-arrest patients.

This study aims to establish the ICP and CPP monitoring process and analyze the result in post-arrest patients, to validate the correlation between direct and non-invasive ICP monitoring indicators, to establish a protocol of management of elevated ICP and insufficient CPP in post-arrest care, to establish a protocol for personalizing CPP and MAP optimization, and to analyze its impact on neuroprognosis.

Вмешательства

  • Устройство ICP monitoring
    ICP monitoring

Первичные конечные точки

  • ICP difference between different temperature [Срок оценки: 12 hour, day 1, 3, 7 post-ROSC]
Вторичные конечные точки (1)
  • Difference between direct and non-invasive ICP monitoring indicators [Срок оценки: 12 hour, day 1, 3, 7 post-ROSC]

Критерии участия

Критерии включения

  • non-traumatic cardiac arrest
  • admitted to ICU
  • GCS: motor <=5
  • severity: TIMECARD score medium-risk group

Критерии исключения

  • traumatic cardiac arrest
  • pregnancy
  • intracranial hemorrhage
  • coagulopathy
  • anti-platelet or anti-coagulation use
  • terminal illness
  • pre-arrest CPC score >=3
  • GWR < 1.2 on CT or severe hypoxic ischemic encephalopathy
  • CNS infection

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Поддерживающая терапия

Центры проведения

Тайвань · 1 центр
  • National Taiwan University Hospital — Taipei

Публикации

  • Wyckoff MH, Greif R, Morley PT, Ng KC, Olasveengen TM, Singletary EM, Soar J, Cheng A, Drennan IR, Liley HG, Scholefield BR, Smyth MA, Welsford M, Zideman DA, Acworth J, Aickin R, Andersen LW, Atkins D, Berry DC, Bhanji F, Bierens J, Borra V, Bottiger BW, Bradley RN, Bray JE, Breckwoldt J, Callaway CW, Carlson JN, Cassan P, Castren M, Chang WT, Charlton NP, Chung SP, Considine J, Costa-Nobre DT, C PMID 36325905
  • Kirkegaard H, Taccone FS, Skrifvars M, Soreide E. Postresuscitation Care after Out-of-hospital Cardiac Arrest: Clinical Update and Focus on Targeted Temperature Management. Anesthesiology. 2019 Jul;131(1):186-208. doi: 10.1097/ALN.0000000000002700. PMID 31021845
  • Nolan JP, Soar J, Cariou A, Cronberg T, Moulaert VR, Deakin CD, Bottiger BW, Friberg H, Sunde K, Sandroni C. European Resuscitation Council and European Society of Intensive Care Medicine Guidelines for Post-resuscitation Care 2015: Section 5 of the European Resuscitation Council Guidelines for Resuscitation 2015. Resuscitation. 2015 Oct;95:202-22. doi: 10.1016/j.resuscitation.2015.07.018. No abst PMID 26477702
  • Neumar RW, Nolan JP, Adrie C, Aibiki M, Berg RA, Bottiger BW, Callaway C, Clark RS, Geocadin RG, Jauch EC, Kern KB, Laurent I, Longstreth WT Jr, Merchant RM, Morley P, Morrison LJ, Nadkarni V, Peberdy MA, Rivers EP, Rodriguez-Nunez A, Sellke FW, Spaulding C, Sunde K, Vanden Hoek T. Post-cardiac arrest syndrome: epidemiology, pathophysiology, treatment, and prognostication. A consensus statement fr PMID 18948368
  • Nolan JP, Sandroni C, Bottiger BW, Cariou A, Cronberg T, Friberg H, Genbrugge C, Haywood K, Lilja G, Moulaert VRM, Nikolaou N, Olasveengen TM, Skrifvars MB, Taccone F, Soar J. European Resuscitation Council and European Society of Intensive Care Medicine guidelines 2021: post-resuscitation care. Intensive Care Med. 2021 Apr;47(4):369-421. doi: 10.1007/s00134-021-06368-4. Epub 2021 Mar 25. PMID 33765189
  • Sandroni C, Skrifvars MB, Taccone FS. Brain monitoring after cardiac arrest. Curr Opin Crit Care. 2023 Apr 1;29(2):68-74. doi: 10.1097/MCC.0000000000001023. Epub 2023 Feb 16. PMID 36762679
  • Gueugniaud PY, Garcia-Darennes F, Gaussorgues P, Bancalari G, Petit P, Robert D. Prognostic significance of early intracranial and cerebral perfusion pressures in post-cardiac arrest anoxic coma. Intensive Care Med. 1991;17(7):392-8. doi: 10.1007/BF01720676. PMID 1774392
  • Sekhon MS, Griesdale DE, Ainslie PN, Gooderham P, Foster D, Czosnyka M, Robba C, Cardim D. Intracranial pressure and compliance in hypoxic ischemic brain injury patients after cardiac arrest. Resuscitation. 2019 Aug;141:96-103. doi: 10.1016/j.resuscitation.2019.05.036. Epub 2019 Jun 8. PMID 31185256

Идентификаторы

NCT: NCT06601842 · 202407092RINE

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗