Aerosolized Endotracheal Lidocaine to Avoid Intracranial Pressure Spikes in Patients With Severe Traumatic Brain Injury
Overview
- Phase
- Phase 4
- Intervention
- aerosolized 2% lidocaine (20mg/ml)
- Conditions
- Traumatic Brain Injury
- Sponsor
- The University of Texas Health Science Center, Houston
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Maximum difference between baseline ICP and highest ICP levels as measured by the ICP monitor in instilled lidocaine versus nebulized lidocaine
- Status
- Completed
- Last Updated
- 3 months ago
Overview
Brief Summary
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).
Investigators
Thao L Nguyen
Assistant Professor
The University of Texas Health Science Center, Houston
Eligibility Criteria
Inclusion Criteria
- •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).
Exclusion Criteria
- •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)
Arms & Interventions
aerosolized lidocaine then Instilled lidocaine solution then instilled saline solution
Treatment will be performed before the endotracheal suctioning
Intervention: aerosolized 2% lidocaine (20mg/ml)
aerosolized lidocaine then Instilled lidocaine solution then instilled saline solution
Treatment will be performed before the endotracheal suctioning
Intervention: instilled 0.9% sodium chloride (NS)
aerosolized lidocaine then Instilled lidocaine solution then instilled saline solution
Treatment will be performed before the endotracheal suctioning
Intervention: instilled 2% lidocaine solution
aerosolized lidocaine then Instilled lidocaine solution then instilled saline solution
Treatment will be performed before the endotracheal suctioning
Intervention: Endotracheal Suctioning (ETS)
aerosolized lidocaine then instilled saline solution then Instilled lidocaine solution
Treatment will be performed before the endotracheal suctioning
Intervention: aerosolized 2% lidocaine (20mg/ml)
aerosolized lidocaine then instilled saline solution then Instilled lidocaine solution
Treatment will be performed before the endotracheal suctioning
Intervention: instilled 0.9% sodium chloride (NS)
aerosolized lidocaine then instilled saline solution then Instilled lidocaine solution
Treatment will be performed before the endotracheal suctioning
Intervention: instilled 2% lidocaine solution
aerosolized lidocaine then instilled saline solution then Instilled lidocaine solution
Treatment will be performed before the endotracheal suctioning
Intervention: Endotracheal Suctioning (ETS)
Instilled lidocaine solution then aerosolized lidocaine then instilled saline solution
Treatment will be performed before the endotracheal suctioning
Intervention: aerosolized 2% lidocaine (20mg/ml)
Instilled lidocaine solution then aerosolized lidocaine then instilled saline solution
Treatment will be performed before the endotracheal suctioning
Intervention: instilled 0.9% sodium chloride (NS)
Instilled lidocaine solution then aerosolized lidocaine then instilled saline solution
Treatment will be performed before the endotracheal suctioning
Intervention: instilled 2% lidocaine solution
Instilled lidocaine solution then aerosolized lidocaine then instilled saline solution
Treatment will be performed before the endotracheal suctioning
Intervention: Endotracheal Suctioning (ETS)
Instilled lidocaine solution then instilled saline solution then aerosolized lidocaine
Treatment will be performed before the endotracheal suctioning
Intervention: aerosolized 2% lidocaine (20mg/ml)
Instilled lidocaine solution then instilled saline solution then aerosolized lidocaine
Treatment will be performed before the endotracheal suctioning
Intervention: instilled 0.9% sodium chloride (NS)
Instilled lidocaine solution then instilled saline solution then aerosolized lidocaine
Treatment will be performed before the endotracheal suctioning
Intervention: instilled 2% lidocaine solution
Instilled lidocaine solution then instilled saline solution then aerosolized lidocaine
Treatment will be performed before the endotracheal suctioning
Intervention: Endotracheal Suctioning (ETS)
Instilled saline solution then aerosolized lidocaine then Instilled lidocaine solution
Treatment will be performed before the endotracheal suctioning
Intervention: aerosolized 2% lidocaine (20mg/ml)
Instilled saline solution then aerosolized lidocaine then Instilled lidocaine solution
Treatment will be performed before the endotracheal suctioning
Intervention: instilled 0.9% sodium chloride (NS)
Instilled saline solution then aerosolized lidocaine then Instilled lidocaine solution
Treatment will be performed before the endotracheal suctioning
Intervention: instilled 2% lidocaine solution
Instilled saline solution then aerosolized lidocaine then Instilled lidocaine solution
Treatment will be performed before the endotracheal suctioning
Intervention: Endotracheal Suctioning (ETS)
Instilled saline solution then Instilled lidocaine solution then aerosolized lidocaine
Treatment will be performed before the endotracheal suctioning
Intervention: aerosolized 2% lidocaine (20mg/ml)
Instilled saline solution then Instilled lidocaine solution then aerosolized lidocaine
Treatment will be performed before the endotracheal suctioning
Intervention: instilled 0.9% sodium chloride (NS)
Instilled saline solution then Instilled lidocaine solution then aerosolized lidocaine
Treatment will be performed before the endotracheal suctioning
Intervention: instilled 2% lidocaine solution
Instilled saline solution then Instilled lidocaine solution then aerosolized lidocaine
Treatment will be performed before the endotracheal suctioning
Intervention: Endotracheal Suctioning (ETS)
Outcomes
Primary Outcomes
Maximum difference between baseline ICP and highest ICP levels as measured by the ICP monitor in instilled lidocaine versus nebulized lidocaine
Time Frame: from baseline to upto 15 minutes after ETS
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.
Secondary Outcomes
- Number of patients with worsening respiratory dynamics(from baseline to up to 15 minutes after ETS)
- Maximum difference between baseline ICP and highest ICP levels as measured by the ICP monitor in nebulized lidocaine and normal saline(from baseline to up to 15 minutes after ETS)