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临床试验/NCT06537492
NCT06537492尚未招募不适用

Synergy of Elevation of the Head and Thorax and Resuscitative Endovascular Balloon Occlusion of the Aorta During Out-of-Hospital Cardiac Arrest: a Pilot Study

University Hospital, Grenoble2 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2024年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
35
试验地点
2
主要终点
Mean Arterial Pressure (MAP)

研究概览

简要总结

Long-term neurological outcome after successful resuscitation of cardiac arrest remains poor, mainly due to cerebral hypoperfusion and severe hypoxic-ischemic brain injuries. Automated head and chest elevation during cardiopulmonary resuscitation (AHUP-CPR) improves cerebral perfusion by decreasing the intracranial pressure and increasing cerebral perfusion in experimental pig studies. The addition of an impedance threshold device (ITD) and active chest compression-decompression device (ACD) improved hemodynamics and cerebral perfusion. In addition, early implementation of AHUP-CPR in patients with out-of-hospital cardiac arrest (OHCA) was associated with improved survival to hospital discharge, in a multicenter observational study. A 2-year prospective clinical trial in Grenoble evaluating this combination was just completed. This study showed for the first time that the value of end-tidal CO2 (EtCO2), a surrogate for cardiopulmonary resuscitation (CPR) quality and cardiac output, measured with this combination therapy, was significantly higher than with standard CPR.

Resuscitative endovascular balloon occlusion of the aorta (REBOA) has recently been proposed during CPR. This technique temporarily diverts blood flow to the coronary and cerebral circulation. Its beneficial effect on hemodynamics, cerebral blood flow and survival has been experimentally validated. In several feasibility studies, encouraging results were observed by slightly optimizing cerebral perfusion and coronary pressure when REBOA was used in combination with standard CPR.

In a porcine model of cardiac arrest, the addition of REBOA to AHUP CPR was associated with a marked improvement in coronary perfusion pressure and near-normalization of cerebral perfusion pressure. These two interventions act synergistically. REBOA directs flow and pressure to the heart and brain, while AHUP CPR improves preload on the right side of the heart and reduces intracranial pressure.

The aims of this clinical investigation are to assess the feasibility of placing a REBOA catheter combined with automated CPR with head and chest elevation, and to quantify the associated changes in clinical parameters for OHCA.

详细描述

Cardiac arrest remains a leading cause of death, currently affecting more than 275,000 patients in Europe and in the US, annually. As recommended by the American Heart Association (AHA) and the European Resuscitation Council (ERC), the current standard of care for patients with an out-of-hospital cardiac arrest (OHCA) includes manual cardiopulmonary resuscitation (S-CPR). Nearly two-thirds of all patients who suffer from sudden cardiac death are male and their average age is approximately 65 years old. Survival rates from this major health epidemic have remained largely unchanged for decades.

The current standard of care for patients with an out-of-hospital cardiac arrest (OHCA) includes manual cardiopulmonary resuscitation (CPR) delivered at a rate of 100 compressions per minute with a depth of 5 cm (maximum 6 cm). Periodic positive pressure ventilations are recommended to assure adequate oxygenation and periodic inflation of the lungs. This method of CPR has been shown in animals to provide 15-30% of normal blood flow to the heart and brain. Although closed-chest manual S-CPR was initially described more than 50 years ago, survival rates remain low. In Europe and in the US, survival with favorable neurological outcome for all patients following OHCA and treated with S-CPR averages <6% (ranging from <1% to 20%). In addition to the challenges associated with performance of high-quality CPR in a timely manner, closed chest manual CPR is inherently limited due to the lack of mechanical optimization of flow and pressure with conventional CPR. The consequence of this limitation is that blood flow is far less than normal to the brain and other vital organs and brain pressures during the compression phase are too high. Better alternatives that more closely mimic normal physiology are needed.

Automated head and thorax elevation during cardiopulmonary resuscitation (AHUP-CPR) improves cerebral perfusion by decreasing intra-cranial pressure and increasing cerebral perfusion in experimental swine studies. The addition of an impedance threshold device (ITD) and active chest compression-decompression (ACD) improved hemodynamics and cerebral perfusion. Moreover, early implementation of AHUP in out-of-hospital cardiac arrest (OHCA) patients was associated with better survival to hospital discharge, in a multicenter observational study. The investigator had just completed a 2-year prospective clinical trial in Grenoble assessing this combination. This study showed, for the first time, that End-Tidal CO2 value, a surrogate for CPR quality and cardiac output, measured using this combination therapy, was significantly higher compared with standard CPR.

Moreover, it was recently showed the importance of an early implementation of these devices to improve survival. Also, as all these devices have a European Union declaration of conformity (CE mark), this technique of CPR should be proposed as a basic life support, done by the rescuers.

The Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) involves inserting a catheter with a balloon at its tip into a large artery, typically the femoral artery. The catheter is threaded through the blood vessels until it reaches the aorta. Once the catheter is in place, the balloon is inflated to temporarily stop blood flow in the aorta. This halts the blood flow to the lower part of the body and redirects it to the critical organs in the chest and brain. REBOA is widely used in acute trauma care in order to stop massive hemorrhages in the lower part of the body. The use of REBOA was proposed for traumatic cardiac arrest in the latest European Resuscitation Council (ERC) guidelines as an option to stop bleeding. However, REBOA has recently been proposed at the early phase of non-traumatic cardiac arrest in case of failure of initial resuscitation's maneuvers (CPR and first defibrillations attempts). This technique temporarily diverts blood flow towards the coronary and cerebral circulation. It has already shown that, during CPR, when coronary perfusion pressure increase, the chance of ROSC increase too. Moreover, REBOA could increase mean arterial pressure and thus increase cerebral perfusion pressure, defined by the difference between mean arterial pressure and intracranial pressure. The beneficial effects on hemodynamics, cerebral blood flow and survival of REBOA have been already validated experimentally.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patient with age over or equal to 18 years old
  • Patient with a witnessed medical cardiac arrest and with a no-flow duration under 10 min
  • Patient with EtCO2 greater than 20 mmHg at REBOA team arrival
  • Patient located in the Grenoble Metropolitan area
  • Patient affiliated to French social security

排除标准

  • Patient with ROSC before REBOA placement.
  • Patient eligible to extracorporeal life support (according to local guidelines).
  • CA of traumatic origin (including drowning or hanging).
  • Patients whose size is not adapted to the LUCAS device: height of the sternum from 170 to 303 mm or maximum chest width of 449 mm. The use of the LUCAS device is not subject to a patient weight condition.
  • Cardiac arrest for which resuscitation seems unjustified (inevitable death, terminally ill irreversible condition, too long duration of cardiac arrest, advance personal directives of no-resuscitation).
  • Obvious pregnancy at inclusion.
  • Subject in a period of exclusion from another clinical investigation.
  • Patients with a femoral arterial access site that cannot accommodate an 8 Fr (minimum) introduces sheath

结局指标

主要结局

Mean Arterial Pressure (MAP)

时间窗: Baseline

Difference in mean arterial pressure (MAP) over a 5s period before the initiation of balloon inflation compared 3 minutes after initiation of balloon inflation in a patient treated with AHUP-CPR

次要结局

  • REBOA Placement(Baseline)
  • Ventilatory parameter: airway pressure(Out-of-hospital care)
  • Compression arterial pressure (CP)(Baseline)
  • Survival(30-day, 3 months)
  • Blood vessel damage(30-day)
  • Arterial thromboembolism(30-day)
  • Lower extremity amputation(30-day)
  • Return to spontaneous circulation (ROSC).(Baseline, 30-day, 3 months)
  • Patients discharged alive.(30-day)
  • Ventilatory parameter: tidal volume(Out-of-hospital care)
  • End-Tidal CO2 (EtCO2)(Baseline)
  • Brain regional O2 saturation (rSO2)(Baseline)
  • Lower extremity paralysis(30-day)
  • Ventilatory parameter: flow(Out-of-hospital care)
  • Decompression arterial pressure (DAP)(Baseline)
  • Neurological status(30-day, 3 months)
  • Renal failure(30-day)

研究者

发起方
University Hospital, Grenoble
申办方类型
Other
责任方
Sponsor

研究点 (2)

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