Timing of Invasive Intracranial Pressure Monitoring Between Neurosurgeons and Intensive Care Physicians
试验速览
- 阶段
- 不适用
- 入组人数
- 64
- 试验地点
- 18
- 主要终点
- To compare timing of invasive intracranial pressure monitoring performed by intensive care physicians and neurosurgeons
研究概览
简要总结
Invasive intracranial pressure monitoring takes on essential importance in patients with traumatic brain injury and in all cerebral pathologies in which intracranial hypertension is the main cause of death.
Prolonged Intracranial Hypertension has been related to poor outcome and its occurrence has therefore to be assessed as soon as possible.
Invasive intracranial pressure monitoring performed by placing an intracerebral catheter is currently the gold standard technique for continuous ICP invasive monitoring. This maneuver has usually been performed by neurosurgeons, but recently this procedure has more often been carried out by intensivists, at the bedside.
Management of intracranial pressure handling and treatment is currently achieved by joint decisions between neurosurgeons and intensive care physicians, but differences in logistic matters and in the executive availability could impact on the dose of intracranial pressure to which patient is exposed.
The aim of this study is to compare timing of invasive intracranial pressure monitoring placement performed by intensive care physicians and neurosurgeons and to detect possible differences in the incidence of complications between the two groups.
详细描述
This perspective, multicentric and observational study will enroll patients at risk for developing intracranial hypertension, for whom it is thought invasive ICP monitoring is crucial for achieving the most appropriate treatment.
Indication to invasive ICP monitoring and its modalities will be set through a joint decision between neurosurgeons and intensive care physician, which will be led by clinical and instrumental data.
This study will be carried out in Intensive Care Unit and in Neurosurgery department.
Sample size assessment:
Sample size assessment has been performed by Monte Carlo simulation (B=500). Assuming a timing decrease (T2-T1) of 20 minutes in the procedure carried out by an intensivist compared to a neurosurgeon, with a mean time of 100 minutes, a standard deviation between center and intra-center of 10 minutes, 16 centers, each one with the same number of patients and a balance 1:1 between the two groups (intensivist:neurosurgeon), a total number of 64 patients (32 treated by intensivists and 32 by neurosurgeons), it allows us to evaluate the interest effect with a power of at least 95%, and a significance level of 5%.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •All patients with acute cerebral pathology with urgent indication to invasive intracranial pressure monitoring (intraparenchymal and intraventricular)
- •Age greater than or equal to 18 years
排除标准
- •Patients in whom indication to intraventricular catheter placement is stated for reasons other than the need of ICP monitoring (e.g. CSF drainage)
- •Patients in whom indication to invasive intracranial pressure monitoring is not an urgent request
- •Patients in whom a significative coagulation disorder is a contraindication for procedure
结局指标
主要结局
To compare timing of invasive intracranial pressure monitoring performed by intensive care physicians and neurosurgeons
时间窗: The time frame, will be from when the suspicion of a potential increase in ICP is given to when the actual skin incision for the insertion of the invasive catheter placement is performed. From indication up to 5 hours.
The time frame, which also represents the main outcome of this study, is defined as the time-difference between the moment when indication of invasive ICP monitoring is given and the moment when the skin incision is performed for ICP monitoring placement.
次要结局
- Length of ICU stay(ICU admission to discharge, up to 30 days)
- duration of mechanical ventilation(from initiation of mechanical ventilation to weaning from the ventilator, up to 30 days.)
- Comparative evaluation of post-procedural complications between intensivists and neurosurgeons(procedure to hospital discharge (in case of malfunction of the catheter, time is up to 12 hours after placement))
- length of hospital stay(hospital admission to discharge, up to 30 days)
- Glasgow Outcome Score at 3 months(3 months after the acute event)
研究者
Dr. Frank Rasulo
Associate Professor in Anesthesiology and Intensive Care
Università degli Studi di Brescia