Aerosolized Endotracheal Lidocaine to Avoid Intracranial Pressure Spikes in Patients With Severe Traumatic Brain Injury

The University of Texas System (UT)

Status and phase: Enrolling; Phase 4

Conditions: Traumatic Brain Injury

Treatments: Drug: instilled 0.9% sodium chloride (NS); Drug: aerosolized 2% lidocaine (20mg/ml); Procedure: Endotracheal Suctioning (ETS); Drug: instilled 2% lidocaine solution

Study type: Interventional

Funder types: Other

Identifiers

NCT05058677

HSC-MS-21-0254

Details and patient eligibility

About

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).

Enrollment: 12 estimated patients

Sex: All

Ages: Under 16 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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12 participants in 6 patient groups

aerosolized lidocaine then Instilled lidocaine solution then instilled saline solution

Experimental group

Description:

Treatment will be performed before the endotracheal suctioning

Treatment:

Drug: instilled 2% lidocaine solution

Procedure: Endotracheal Suctioning (ETS)

Drug: aerosolized 2% lidocaine (20mg/ml)

Drug: instilled 0.9% sodium chloride (NS)

aerosolized lidocaine then instilled saline solution then Instilled lidocaine solution

Experimental group

Description:

Treatment will be performed before the endotracheal suctioning

Treatment:

Drug: instilled 2% lidocaine solution

Procedure: Endotracheal Suctioning (ETS)

Drug: aerosolized 2% lidocaine (20mg/ml)

Drug: instilled 0.9% sodium chloride (NS)

Instilled lidocaine solution then aerosolized lidocaine then instilled saline solution

Experimental group

Description:

Treatment will be performed before the endotracheal suctioning

Treatment:

Drug: instilled 2% lidocaine solution

Procedure: Endotracheal Suctioning (ETS)

Drug: aerosolized 2% lidocaine (20mg/ml)

Drug: instilled 0.9% sodium chloride (NS)

Instilled lidocaine solution then instilled saline solution then aerosolized lidocaine

Experimental group

Description:

Treatment will be performed before the endotracheal suctioning

Treatment:

Drug: instilled 2% lidocaine solution

Procedure: Endotracheal Suctioning (ETS)

Drug: aerosolized 2% lidocaine (20mg/ml)

Drug: instilled 0.9% sodium chloride (NS)

Instilled saline solution then aerosolized lidocaine then Instilled lidocaine solution

Experimental group

Description:

Treatment will be performed before the endotracheal suctioning

Treatment:

Drug: instilled 2% lidocaine solution

Procedure: Endotracheal Suctioning (ETS)

Drug: aerosolized 2% lidocaine (20mg/ml)

Drug: instilled 0.9% sodium chloride (NS)

Instilled saline solution then Instilled lidocaine solution then aerosolized lidocaine

Experimental group

Description:

Treatment will be performed before the endotracheal suctioning

Treatment:

Drug: instilled 2% lidocaine solution

Procedure: Endotracheal Suctioning (ETS)

Drug: aerosolized 2% lidocaine (20mg/ml)

Drug: instilled 0.9% sodium chloride (NS)