A Randomized Controlled Study of the NEURESCUE Device as an Adjunct to Advanced Cardiac Life Support

Обзор

The NEURESCUE device is the first intelligent balloon catheter for aortic balloon occlusion (ABO), an emergency technique that supercharges blood flow to the heart and brain within one minute from deployment. The catheter-based device is delivered via the femoral artery, temporarily inflating a soft balloon in the descending to redirect blood flow towards the upper body. The purpose of this study is to compare the clinical safety and performance of Advanced Cardiovascular Life Support (ACLS) versus ACLS in combination with Aortic Balloon Occlusion (ABO) using the NEURESCUE device in subjects with cardiac arrest.

Подробное описание

Subjects will be randomized into two arms: ACLS treatment or ACLS + ABO treatment. Those in the ACLS treatment arm will receive standard of care treatment for cardiac arrest, while those in Arm 2 will receive ACLS in combination with ABO.

The NEURESCUE device is an aortic balloon catheter designed to temporarily occlude the aorta. During the treatment, the NEURESCUE Catheter will be placed in the descending aorta and be connected to the NEURESCUE Assistant. The NEURESCUE Assistant facilitates pressure-regulated inflation and deflation of the balloon.

Throughout the treatment, cardiac rhythm and return of spontaneous circulation (ROSC) will be monitored.

The subject will be monitored for a total of 4 visits, where a 90-days follow-up will account for the last visit.

Вмешательства

• Процедура Advanced Cardiac Life Support (ACLS)
  Standard of care Advanced Cardiac Life Support (ACLS) consists of cardiopulmonary resuscitation (CPR), airway management, ventilation and defibrillation.
• Устройство Aortic balloon occlusion (ABO)
  Aortic balloon occlusion (ABO) is a technique that diverts blood flow towards the coronary and cerebral circulation. ABO is investigated as an adjunct to the treatment of cardiac arrest. In this study ABO is performed using the NEURESCUE Catheter, which is inserted through an introducer in the femoral artery, and thereby inserted into the aorta during uninterrupted Advanced Cardiac Life Support (ACLS). The balloon is then temporarily inflated as an adjunct to the treatment of cardiac arrest.

Первичные конечные точки

• Resuscitation [Срок оценки: Measured from 10 minutes after randomization to 70 minutes after randomization]

Вторичные конечные точки (6)

• Epinephrine [Срок оценки: Measured from 10 minutes after randomization to 70 minutes after randomization]
• Procedures [Срок оценки: Measured from 10 minutes after randomization to 90 days post cardiac arrest]
• (S)A(D)E [Срок оценки: Measured from randomization to 90 days post cardiac arrest]
• CPC score [Срок оценки: Measured at dischage or at 7 days post cardiac arrest, and 90 days post cardiac arrest]
• EQ-5D [Срок оценки: Measured 90 days post cardiac arrest]
• Survival [Срок оценки: Measured at dischage or at 7 days post cardiac arrest, and 90 days post cardiac arrest]

Критерии участия

Критерии включения

• Age ≥18 and ≤80 years
• Witnessed arrest
• CPR initiated within 7 min of arrest
• CPR time less than 40 min at enrollment
• Non-shockable rhythm

Критерии исключения

• Traumatic cardiac arrest
• Known pregnancy
• Known terminal disease
• Known do-not-attempt-CPR order
• Known opposition to study participation

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Германия · 2 центра

• Charité - Universitätsklinikum Berlin — Berlin
• University Hospital Heidelberg — Heidelberg

Идентификаторы

NCT: NCT06793033 · ARISE RCT

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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