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

Phase 4

Recruiting

• Conditions: Traumatic Brain Injury
• Interventions: Drug: aerosolized 2% lidocaine (20mg/ml); Drug: instilled 0.9% sodium chloride (NS); Drug: instilled 2% lidocaine solution; Procedure: Endotracheal Suctioning (ETS)

• Registration Number: NCT05058677
• Lead Sponsor: The University of Texas Health Science Center, Houston

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-09-16
• Study First Submitted QC: 2021-09-16
• Study First Posted: 2021-09-28
• Study Start: 2021-11-09
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-04
• Last Update Posted: 2024-12-06
• Primary Completion: 2025-06-30
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 12

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).

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Instilled lidocaine solution then aerosolized lidocaine then instilled saline solution	instilled 0.9% sodium chloride (NS)	Treatment will be performed before the endotracheal suctioning
Instilled lidocaine solution then instilled saline solution then aerosolized lidocaine	instilled 0.9% sodium chloride (NS)	Treatment will be performed before the endotracheal suctioning
aerosolized lidocaine then Instilled lidocaine solution then instilled saline solution	aerosolized 2% lidocaine (20mg/ml)	Treatment will be performed before the endotracheal suctioning
aerosolized lidocaine then instilled saline solution then Instilled lidocaine solution	aerosolized 2% lidocaine (20mg/ml)	Treatment will be performed before the endotracheal suctioning
aerosolized lidocaine then instilled saline solution then Instilled lidocaine solution	instilled 2% lidocaine solution	Treatment will be performed before the endotracheal suctioning
Instilled lidocaine solution then instilled saline solution then aerosolized lidocaine	Endotracheal Suctioning (ETS)	Treatment will be performed before the endotracheal suctioning
aerosolized lidocaine then Instilled lidocaine solution then instilled saline solution	instilled 0.9% sodium chloride (NS)	Treatment will be performed before the endotracheal suctioning
aerosolized lidocaine then Instilled lidocaine solution then instilled saline solution	Endotracheal Suctioning (ETS)	Treatment will be performed before the endotracheal suctioning
Instilled lidocaine solution then instilled saline solution then aerosolized lidocaine	aerosolized 2% lidocaine (20mg/ml)	Treatment will be performed before the endotracheal suctioning
aerosolized lidocaine then Instilled lidocaine solution then instilled saline solution	instilled 2% lidocaine solution	Treatment will be performed before the endotracheal suctioning
aerosolized lidocaine then instilled saline solution then Instilled lidocaine solution	instilled 0.9% sodium chloride (NS)	Treatment will be performed before the endotracheal suctioning
Instilled saline solution then aerosolized lidocaine then Instilled lidocaine solution	aerosolized 2% lidocaine (20mg/ml)	Treatment will be performed before the endotracheal suctioning
Instilled saline solution then Instilled lidocaine solution then aerosolized lidocaine	instilled 2% lidocaine solution	Treatment will be performed before the endotracheal suctioning
aerosolized lidocaine then instilled saline solution then Instilled lidocaine solution	Endotracheal Suctioning (ETS)	Treatment will be performed before the endotracheal suctioning
Instilled lidocaine solution then aerosolized lidocaine then instilled saline solution	aerosolized 2% lidocaine (20mg/ml)	Treatment will be performed before the endotracheal suctioning
Instilled lidocaine solution then aerosolized lidocaine then instilled saline solution	instilled 2% lidocaine solution	Treatment will be performed before the endotracheal suctioning
Instilled lidocaine solution then aerosolized lidocaine then instilled saline solution	Endotracheal Suctioning (ETS)	Treatment will be performed before the endotracheal suctioning
Instilled lidocaine solution then instilled saline solution then aerosolized lidocaine	instilled 2% lidocaine solution	Treatment will be performed before the endotracheal suctioning
Instilled saline solution then aerosolized lidocaine then Instilled lidocaine solution	instilled 0.9% sodium chloride (NS)	Treatment will be performed before the endotracheal suctioning
Instilled saline solution then aerosolized lidocaine then Instilled lidocaine solution	instilled 2% lidocaine solution	Treatment will be performed before the endotracheal suctioning
Instilled saline solution then Instilled lidocaine solution then aerosolized lidocaine	aerosolized 2% lidocaine (20mg/ml)	Treatment will be performed before the endotracheal suctioning
Instilled saline solution then Instilled lidocaine solution then aerosolized lidocaine	instilled 0.9% sodium chloride (NS)	Treatment will be performed before the endotracheal suctioning
Instilled saline solution then aerosolized lidocaine then Instilled lidocaine solution	Endotracheal Suctioning (ETS)	Treatment will be performed before the endotracheal suctioning
Instilled saline solution then Instilled lidocaine solution then aerosolized lidocaine	Endotracheal Suctioning (ETS)	Treatment will be performed before the endotracheal suctioning

Primary Outcome Measures

Name	Time	Method
Maximum difference between baseline ICP and highest ICP levels as measured by the ICP monitor in instilled lidocaine versus nebulized lidocaine	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 Outcome Measures

Name	Time	Method
Number of patients with worsening respiratory dynamics	from baseline to up to 15 minutes after ETS	This will be measured by increasing oxygenation index or worsening compliance, measured by any increase in the peak pressure for volume ventilated patients.
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	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.

Trial Locations

Locations (1)

The University of Texas Health Science Center at Houston; 🇺🇸 Houston, Texas, United States