Pilot Study : Characterization of Early Brain Injury and Delayed Cerebral Ischemia After Aneurysmal Subarachnoid Hemorrhage by Ultrasound Localization Microscopy (ULM) 3D with an Experimental Medical Device (ESRIR)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Presence of a time-intensity curve (TIC) of contrast agent / Quality of signal
研究概览
简要总结
Aneurysmal subarachnoid hemorrhage (SAH) is a devastating form of stroke, with three major complications : early brain injury (EBI), vasospasm and delayed cerebral ischemia (DCI). Those patients are often given care in neurocritical care. Imaging is particularly useful to diagnose these complications. Brain imaging includes CT scan, MRI and arteriography which are not easily available and need an intrahospital transportation. Furthermore, intrahospital transportation of critically ill patients is associated with significant complications Here, investigators try to show that a new non-invasive bedside device, based on 3D enhanced ultrasonography, is able to detect principal arteries of anterior circulation of the brain.
详细描述
Introduction
Aneurysmal subarachnoid hemorrhage (SAH) is a devastating form of hemorrhagic stroke. Majors complications of aneurysmal SAH include early brain injury (EBI), vasospam and delayed cerebral ischemia (DCI). There are currently only few ways through imaging to diagnose those complication. Transcranial doppler (TCD) is an accessible bedside tool which is efficient, but can only provide indirect evidences. Other brain imaging includes CT scan, MRI and arteriography which are not easily available and are associated with intrahospital transportation of critically ill patients and its morbidity. There are several preclinical evidences that 3D enhanced ultrasonography localizing microscopy could show similar images resolution to angiography while being more accessible.
Materials and methods
this study will include patients with aneurysmal SAH. Aneurysm must be of anterior circulation.The investigators will perform a feasibility research with a new medical device based on ultrasonography localizing microscopy. The standard of care will not be changed, but each patient will also get three bilateral transcranial enhanced (with microbubbles from Sonovue) ultrasonography, one for each period at risk (J0-J2, J4-10, J11-J14). The primary outcome will be the quality of time-intensity curve of the contrast agent, in order to show the quality of signal received. Then, as a secondary outcome, images will be compared to clinical findings. As a pilot study, the investigators plan to include only 15 patients in a monocentric trial.
This device could provide real-time information on blood flow and potential complications such as vasospasm or DCI, allowing for earlier intervention and potentially improving outcomes for SAH patients. Additionally, the bedside nature of this device eliminates the need for intrahospital transportation, reducing the risk of complications associated with moving critically ill patients.
This study aims to assess the feasibility and potential benefits of using 3D enhanced ultrasonography localizing microscopy in the management of aneurysmal SAH. The results of this pilot study could pave the way for larger clinical trials and ultimately lead to improved outcomes for patients with this devastating condition.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
盲法说明
The investigator and care provider can't see the imaging results.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Admitted in neurologic ICU of the CHU Caen, Normandy, for a subarachnoid hemorrhage of the anterior circulation.
- •Usable ultrasound temporal window.
- •18 years old and more.
- •Consent of the participant or the trusted person.
排除标准
- •non-aneurysmal subarachnoid haemorrhage.
- •Contraindication to ultrasound contrast agent Sonovue, including allergies to a compound.
- •Uncontrolled systemic hypertension.
- •Acute respiratory distress syndrome.
- •Pregnancy or breastfeeding mother.
- •Vulnerable person with guardianship or curatorship.
- •Patient not affiliated to french social security system (Sécurité Sociale)
结局指标
主要结局
Presence of a time-intensity curve (TIC) of contrast agent / Quality of signal
时间窗: day 0-2 / day 4-10 / day 11-14
Mathematical models may be used to estimate blood flow parameters after the administration of microbubble contrast agents. A time-intensity curve (TIC) may be created to reflect the intravascular transit of the contrast agent. TICs reflect the average intensity in a region of interest, measured in absolute intensity units, over time in seconds. Plotting TIC in a given frame allows for quantification of various parameters, including time to peak, peak intensity, area under the curve, wash-in and wash-out time, and mean transit time. Some of these parameters, such as peak intensity and area under the curve, reflect local blood volume in the region of interest, whereas, other parameters (time to peak intensity, wash-in/wash-out time) are more reflective of blood flow.
次要结局
- Agreement between data from 3D ultrasonography localizing miroscopy and clinical parameters of early brain injury, cerebral vasospam and delayed cerebral ischemia(day 0-2 / day 4-10 / day 11-14)
- Ability to detect principal arteries of anterior circulation(day 0-2 / day 4-10 / day 11-14)
- Variability of measurement(day 0-2 / day 4-10 / day 11-14)