Evaluation of Cerebral Microcirculation Using Non-invasive Contrast-enhanced Ultrasound and Microbubbles Sonovue Administration After Clinical Cardiorespiratory Arrest
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Mean change of the Peak intensity from baseline (dB).
研究概览
简要总结
Brain microcirculation alterations may be involved in comatose patients and non-survivors after cardiorespiratory arrest. For a three day-period, we investigate brain microcirculation using contrast-enhanced ultrasound with contrast Sonovue injection in patients with successful resuscitation after out-hospital or in-hospital cardiorespiratory arrest.
详细描述
Brain ultrasound, extracranial echo-color duplex and ocular ultrasound (IE 33, Philips Medical System, the Netherlands) are performed in the first 24 hours, at 48 hours, and at 72-96 hours after successful resuscitation after out-hospital or in-hospital cardiorespiratory arrest.
Ultrasound examinations are performed in four steps to 1) evaluate the global cerebral blood volume, 2) to estimate the presence or absence of cerebral autoregulation, and 3) to qualitatively evaluate the cerebral perfusion and microcirculation by enhanced microbubbles contrast injection 4) to qualitatively evaluate the intracranial pressure.
Before performing brain ultrasound, echocardiography (IE 33, Philips medical System, the Netherlands) is performed to evaluate the cardiac output (L/min).
First, the global cerebral blood volume (L/min) is evaluated as the sum of flow volumes of the internal carotid (ICA) and vertebral arteries (VA) extracranial arteries of both sides.The following measurements of flow velocities are taken in each artery: Peak systolic and end-diastolic velocity, time-averaged velocity (TAV), Pulsatility Index (PI). Flow volume (Q) of each artery is determined as Q = TAV x Area ((diameter of the artery /2)² x PI).
Brain ultrasound is performed via temporal windows to measure the mean flow velocities (cm/sec) of the middle cerebral arteries.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ICU patients with successful resuscitation after out-hospital or in-hospital cardiorespiratory arrest
排除标准
- •Younger than 18 years old
- •Pregnancy
- •Acute or history of neurological disorder: stroke, bleeding, trauma, post-neurosurgery, tumor, meningitis.
- •Severe dementia, psychiatric or neuromuscular disability
- •Untreated Acute coronary syndrome
- •Acute Respiratory Distress Syndrome (ARDS) with the ratio of arterial oxygen partial pressure (mmHg) to fractional inspired oxygen (PaO2/ FiO2) less than 150
- •Severe systolic pulmonary hypertension above 90 mmHg
- •Advanced liver cirrhosis with hyperammonemia
- •Uremia > 200mmol/L
- •Acute drug intoxications with coma
- •Acute alcohol intoxication or withdrawal syndrome.
- •Advanced malign diseases.
- •History of allergy to the microbubble contrast SONOVUE.
- •Insufficient echogenicity to ultrasound and incomplete insonation of the intracerebral arteries and brain parenchyma.
- •Significant intracerebral and extracerebral arteries stenosis (≥ 70%) or vertebral artery hypoplasia (3mm).
结局指标
主要结局
Mean change of the Peak intensity from baseline (dB).
时间窗: Comparison to baseline (24 hours after ICU admission) to the two other time points: at 48 hours and at 72 or 96 hours
Qualitative evaluation of brain microcirculation using the variables of the time-intensity curve after Sonovue administration: a reduction of Peak intensity is expected in comatose patients or non-survivors.
Mean change of the time to Peak intensity from baseline (seconds).
时间窗: Comparison to baseline (24 hours after ICU admission) to the two other time points: at 48 hours and at 72 or 96 hours
Qualitative evaluation of brain microcirculation using the variables of the time-intensity curve after Sonovue administration: a reduction of the time to peak intensity is expected in comatose patients or non-survivors.
Mean change of the Area under the curve from baseline (percentage).
时间窗: Comparison to baseline (24 hours after ICU admission) to the two other time points: at 48 hours and at 72 or 96 hours
Qualitative evaluation of brain microcirculation using the variables of the time-intensity curve after Sonovue administration: a reduction of the area under the curve is expected in comatose patients or non-survivors.
Mean change of the optic nerve sheath diameter from baseline (mm)
时间窗: Comparison to baseline (24 hours after ICU admission) to the two other time points: at 48 hours and at 72 or 96 hours
Qualitative estimation of intracranial pressure using ocular ultrasound to measure the optic nerve sheath diameter. Elevation of intracranial pressure with increase of this diameter above 0.55 mm is expected in comatose patients or non-survivors.
Mean change of the Mean transit time from baseline (seconds)
时间窗: Comparison to baseline (24 hours after ICU admission) to the two other time points: at 48 hours and at 72 or 96 hours
Qualitative evaluation of brain microcirculation using the variables of the time-intensity curve after Sonovue administration: a prolonged of Mean transit time is expected in comatose patients or non-survivors.
Testing cerebral autoregulation: Transient Hyperemic test- Absence or presence from baseline
时间窗: Comparison to baseline (24 hours after ICU admission) to the two other time points: at 48 hours and at 72 or 96 hours
Absence of cerebral autoregulation is considered if there is no change in flow velocities of the middle cerebral arteries after short compression of the common carotid arteries occur comparing with the value prior to compression.
次要结局
- Mean change of the mean velocities of the middle cerebral arteries from baseline (cm/second)(Comparison to baseline (24 hours after ICU admission) to the two other time points: at 48 hours and at 72 or 96 hours)
- Mean change of global cerebral blood flow from baseline (L/minute)(Comparison to baseline (24 hours after ICU admission) to the two other time points: at 48 hours and at 72 or 96 hours)
- Mean change of cardiac output from baseline (L/minute)(Comparison to baseline (24 hours after ICU admission) to the two other time points: at 48 hours and at 72 or 96 hours)
研究者
Duc Nam Nguyen
Clinical Professor
Universitair Ziekenhuis Brussel