Aerosolized Endotracheal Lidocaine to Avoid Intracranial Pressure Spikes in Patients With Severe Traumatic Brain Injury
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Change From Baseline Intracranial Pressure (ICP) at 2, 5 and 15 Minutes.
研究概览
简要总结
The purpose of this study is to evaluate the effectiveness of nebulized lidocaine before Endotracheal suctioning (ETS) compared to instilled lidocaine and the effectiveness of aerosolized lidocaine versus instilled normal saline before ETS in attenuating the increase of intracranial pressure (ICP) in severe head injured children and to evaluate the feasibility of a trial involving instilled lidocaine and aerosolized lidocaine for the management of ETS and to evaluate the safety of nebulized lidocaine in traumatic brain injury (TBI) compared to instilled lidocaine and instilled sodium chloride (NS).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients admitted to the PICU of Memorial Hermann Children's Hospital
- •Severe TBI with a Glasgow Coma Scale score 4-8
- •Intubated and mechanically ventilated with an ICP monitor in place.
- •Continuous invasive monitoring of arterial pressure
- •Hemodynamically Stable, defined by normal blood pressure for age before the ETS. We will not exclude patients with norepinephrine to maintain goal blood pressures to maintain Cerebral perfusion pressure(CPP).
排除标准
- •Patients with sustained ICP > 25 for more than 30 minutes mm Hg despite medical or neurosurgical intervention
- •Moderate/Severe Acute respiratory distress syndrome (ARDS) with an oxygenation index > 8
- •Pulmonary hemorrhage
- •Patients receiving neuromuscular blockade
- •Use of other vasopressors for other causes of shock (cardiogenic, hypovolemic and septic)
研究组 & 干预措施
Instilled lidocaine solution then aerosolized lidocaine then instilled saline solution
Treatment will be performed before the endotracheal suctioning
干预措施: instilled 0.9% sodium chloride (NS) (Drug)
Instilled saline solution then aerosolized lidocaine then Instilled lidocaine solution
Treatment will be performed before the endotracheal suctioning
干预措施: instilled 0.9% sodium chloride (NS) (Drug)
aerosolized lidocaine then Instilled lidocaine solution then instilled saline solution
Treatment will be performed before the endotracheal suctioning
干预措施: Endotracheal Suctioning (ETS) (Procedure)
aerosolized lidocaine then instilled saline solution then Instilled lidocaine solution
Treatment will be performed before the endotracheal suctioning
干预措施: instilled 0.9% sodium chloride (NS) (Drug)
aerosolized lidocaine then instilled saline solution then Instilled lidocaine solution
Treatment will be performed before the endotracheal suctioning
干预措施: Endotracheal Suctioning (ETS) (Procedure)
Instilled lidocaine solution then aerosolized lidocaine then instilled saline solution
Treatment will be performed before the endotracheal suctioning
干预措施: aerosolized 2% lidocaine (20mg/ml) (Drug)
Instilled lidocaine solution then aerosolized lidocaine then instilled saline solution
Treatment will be performed before the endotracheal suctioning
干预措施: instilled 2% lidocaine solution (Drug)
Instilled lidocaine solution then aerosolized lidocaine then instilled saline solution
Treatment will be performed before the endotracheal suctioning
干预措施: Endotracheal Suctioning (ETS) (Procedure)
Instilled lidocaine solution then instilled saline solution then aerosolized lidocaine
Treatment will be performed before the endotracheal suctioning
干预措施: aerosolized 2% lidocaine (20mg/ml) (Drug)
Instilled lidocaine solution then instilled saline solution then aerosolized lidocaine
Treatment will be performed before the endotracheal suctioning
干预措施: instilled 2% lidocaine solution (Drug)
Instilled saline solution then aerosolized lidocaine then Instilled lidocaine solution
Treatment will be performed before the endotracheal suctioning
干预措施: aerosolized 2% lidocaine (20mg/ml) (Drug)
Instilled saline solution then aerosolized lidocaine then Instilled lidocaine solution
Treatment will be performed before the endotracheal suctioning
干预措施: instilled 2% lidocaine solution (Drug)
Instilled saline solution then aerosolized lidocaine then Instilled lidocaine solution
Treatment will be performed before the endotracheal suctioning
干预措施: Endotracheal Suctioning (ETS) (Procedure)
Instilled saline solution then Instilled lidocaine solution then aerosolized lidocaine
Treatment will be performed before the endotracheal suctioning
干预措施: aerosolized 2% lidocaine (20mg/ml) (Drug)
Instilled saline solution then Instilled lidocaine solution then aerosolized lidocaine
Treatment will be performed before the endotracheal suctioning
干预措施: instilled 0.9% sodium chloride (NS) (Drug)
Instilled saline solution then Instilled lidocaine solution then aerosolized lidocaine
Treatment will be performed before the endotracheal suctioning
干预措施: instilled 2% lidocaine solution (Drug)
Instilled lidocaine solution then instilled saline solution then aerosolized lidocaine
Treatment will be performed before the endotracheal suctioning
干预措施: instilled 0.9% sodium chloride (NS) (Drug)
aerosolized lidocaine then Instilled lidocaine solution then instilled saline solution
Treatment will be performed before the endotracheal suctioning
干预措施: aerosolized 2% lidocaine (20mg/ml) (Drug)
aerosolized lidocaine then instilled saline solution then Instilled lidocaine solution
Treatment will be performed before the endotracheal suctioning
干预措施: aerosolized 2% lidocaine (20mg/ml) (Drug)
aerosolized lidocaine then instilled saline solution then Instilled lidocaine solution
Treatment will be performed before the endotracheal suctioning
干预措施: instilled 2% lidocaine solution (Drug)
Instilled lidocaine solution then instilled saline solution then aerosolized lidocaine
Treatment will be performed before the endotracheal suctioning
干预措施: Endotracheal Suctioning (ETS) (Procedure)
aerosolized lidocaine then Instilled lidocaine solution then instilled saline solution
Treatment will be performed before the endotracheal suctioning
干预措施: instilled 0.9% sodium chloride (NS) (Drug)
aerosolized lidocaine then Instilled lidocaine solution then instilled saline solution
Treatment will be performed before the endotracheal suctioning
干预措施: instilled 2% lidocaine solution (Drug)
Instilled saline solution then Instilled lidocaine solution then aerosolized lidocaine
Treatment will be performed before the endotracheal suctioning
干预措施: Endotracheal Suctioning (ETS) (Procedure)
结局指标
主要结局
Change From Baseline Intracranial Pressure (ICP) at 2, 5 and 15 Minutes.
时间窗: Baseline and 2, 5, and 15 minutes post-intervention
A Codman Intraparenchymal Catheter will measure the ICP. The ICP will be transduced and measured numerically and continuously in real time on the patient's bedside monitor. ICP Values were recorded at baseline and at 2, 5, and 15 minutes after administration of aerosolized lidocaine, instilled saline solution, or instilled lidocaine solution. Change from baseline is calculated at post intervention time point.
次要结局
- Number of Patients With Worsening Respiratory Dynamics(from baseline to up to 15 minutes after ETS)
研究者
Thao L Nguyen
Assistant Professor
The University of Texas Health Science Center, Houston