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

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).

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • The University of Texas Health Science Center at Houston

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 16 years (Child)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: aerosolized lidocaine then Instilled lidocaine solution then instilled saline solution; Treatment will be performed before the endotracheal suctioning	Drug: aerosolized 2% lidocaine (20mg/ml); The aerosolized solution to be used is 2% lidocaine (20 mg/ml) at a dose of 1.5 mg/kg with a maximum volume of 3 ml or adjusted to a volume of 3 ml with addition of NS solution.The aerosolized solution will be administered with an Aerogen ultrasonic nebulizer, which is standard of care for administering aerosolized solutions in our pediatric intensive care unit (PICU).After each treatment a 3-minute interval will be allowed prior to ETS and there will be a 4-6 hour wash out period between each treatment.; Drug: instilled 0.9% sodium chloride (NS); The instilled solution will be given with a standard 3-5 ml syringe.After each treatment a 3-minute interval will be allowed prior to ETS and there will be a 4-6 hour wash out period between each treatment.; Drug: instilled 2% lidocaine solution; The instilled 2 % lidocaine solution used will be 1.5 mg/kg, with a max volume of 3 ml or adjusted to a volume of 3 ml with addition of NS solution.The instilled solution will be given with a standard 3-5 ml syringe.After each treatment a 3-minute interval will be allowed prior to ETS and there will be a 4-6 hour wash out period between each treatment.; Procedure: Endotracheal Suctioning (ETS); ETS will be performed in a single pass using a closed-system suctioning. Suction will be applied only on withdrawal of the catheter and fraction of inspired oxygen (FIO2) will remain at 100% for 60 seconds following suctioning and then returned to the preprocedural level (baseline).
Experimental: aerosolized lidocaine then instilled saline solution then Instilled lidocaine solution; Treatment will be performed before the endotracheal suctioning	Drug: aerosolized 2% lidocaine (20mg/ml); The aerosolized solution to be used is 2% lidocaine (20 mg/ml) at a dose of 1.5 mg/kg with a maximum volume of 3 ml or adjusted to a volume of 3 ml with addition of NS solution.The aerosolized solution will be administered with an Aerogen ultrasonic nebulizer, which is standard of care for administering aerosolized solutions in our pediatric intensive care unit (PICU).After each treatment a 3-minute interval will be allowed prior to ETS and there will be a 4-6 hour wash out period between each treatment.; Drug: instilled 0.9% sodium chloride (NS); The instilled solution will be given with a standard 3-5 ml syringe.After each treatment a 3-minute interval will be allowed prior to ETS and there will be a 4-6 hour wash out period between each treatment.; Drug: instilled 2% lidocaine solution; The instilled 2 % lidocaine solution used will be 1.5 mg/kg, with a max volume of 3 ml or adjusted to a volume of 3 ml with addition of NS solution.The instilled solution will be given with a standard 3-5 ml syringe.After each treatment a 3-minute interval will be allowed prior to ETS and there will be a 4-6 hour wash out period between each treatment.; Procedure: Endotracheal Suctioning (ETS); ETS will be performed in a single pass using a closed-system suctioning. Suction will be applied only on withdrawal of the catheter and fraction of inspired oxygen (FIO2) will remain at 100% for 60 seconds following suctioning and then returned to the preprocedural level (baseline).
Experimental: Instilled lidocaine solution then aerosolized lidocaine then instilled saline solution; Treatment will be performed before the endotracheal suctioning	Drug: aerosolized 2% lidocaine (20mg/ml); The aerosolized solution to be used is 2% lidocaine (20 mg/ml) at a dose of 1.5 mg/kg with a maximum volume of 3 ml or adjusted to a volume of 3 ml with addition of NS solution.The aerosolized solution will be administered with an Aerogen ultrasonic nebulizer, which is standard of care for administering aerosolized solutions in our pediatric intensive care unit (PICU).After each treatment a 3-minute interval will be allowed prior to ETS and there will be a 4-6 hour wash out period between each treatment.; Drug: instilled 0.9% sodium chloride (NS); The instilled solution will be given with a standard 3-5 ml syringe.After each treatment a 3-minute interval will be allowed prior to ETS and there will be a 4-6 hour wash out period between each treatment.; Drug: instilled 2% lidocaine solution; The instilled 2 % lidocaine solution used will be 1.5 mg/kg, with a max volume of 3 ml or adjusted to a volume of 3 ml with addition of NS solution.The instilled solution will be given with a standard 3-5 ml syringe.After each treatment a 3-minute interval will be allowed prior to ETS and there will be a 4-6 hour wash out period between each treatment.; Procedure: Endotracheal Suctioning (ETS); ETS will be performed in a single pass using a closed-system suctioning. Suction will be applied only on withdrawal of the catheter and fraction of inspired oxygen (FIO2) will remain at 100% for 60 seconds following suctioning and then returned to the preprocedural level (baseline).
Experimental: Instilled lidocaine solution then instilled saline solution then aerosolized lidocaine; Treatment will be performed before the endotracheal suctioning	Drug: aerosolized 2% lidocaine (20mg/ml); The aerosolized solution to be used is 2% lidocaine (20 mg/ml) at a dose of 1.5 mg/kg with a maximum volume of 3 ml or adjusted to a volume of 3 ml with addition of NS solution.The aerosolized solution will be administered with an Aerogen ultrasonic nebulizer, which is standard of care for administering aerosolized solutions in our pediatric intensive care unit (PICU).After each treatment a 3-minute interval will be allowed prior to ETS and there will be a 4-6 hour wash out period between each treatment.; Drug: instilled 0.9% sodium chloride (NS); The instilled solution will be given with a standard 3-5 ml syringe.After each treatment a 3-minute interval will be allowed prior to ETS and there will be a 4-6 hour wash out period between each treatment.; Drug: instilled 2% lidocaine solution; The instilled 2 % lidocaine solution used will be 1.5 mg/kg, with a max volume of 3 ml or adjusted to a volume of 3 ml with addition of NS solution.The instilled solution will be given with a standard 3-5 ml syringe.After each treatment a 3-minute interval will be allowed prior to ETS and there will be a 4-6 hour wash out period between each treatment.; Procedure: Endotracheal Suctioning (ETS); ETS will be performed in a single pass using a closed-system suctioning. Suction will be applied only on withdrawal of the catheter and fraction of inspired oxygen (FIO2) will remain at 100% for 60 seconds following suctioning and then returned to the preprocedural level (baseline).
Experimental: Instilled saline solution then aerosolized lidocaine then Instilled lidocaine solution; Treatment will be performed before the endotracheal suctioning	Drug: aerosolized 2% lidocaine (20mg/ml); The aerosolized solution to be used is 2% lidocaine (20 mg/ml) at a dose of 1.5 mg/kg with a maximum volume of 3 ml or adjusted to a volume of 3 ml with addition of NS solution.The aerosolized solution will be administered with an Aerogen ultrasonic nebulizer, which is standard of care for administering aerosolized solutions in our pediatric intensive care unit (PICU).After each treatment a 3-minute interval will be allowed prior to ETS and there will be a 4-6 hour wash out period between each treatment.; Drug: instilled 0.9% sodium chloride (NS); The instilled solution will be given with a standard 3-5 ml syringe.After each treatment a 3-minute interval will be allowed prior to ETS and there will be a 4-6 hour wash out period between each treatment.; Drug: instilled 2% lidocaine solution; The instilled 2 % lidocaine solution used will be 1.5 mg/kg, with a max volume of 3 ml or adjusted to a volume of 3 ml with addition of NS solution.The instilled solution will be given with a standard 3-5 ml syringe.After each treatment a 3-minute interval will be allowed prior to ETS and there will be a 4-6 hour wash out period between each treatment.; Procedure: Endotracheal Suctioning (ETS); ETS will be performed in a single pass using a closed-system suctioning. Suction will be applied only on withdrawal of the catheter and fraction of inspired oxygen (FIO2) will remain at 100% for 60 seconds following suctioning and then returned to the preprocedural level (baseline).
Experimental: Instilled saline solution then Instilled lidocaine solution then aerosolized lidocaine; Treatment will be performed before the endotracheal suctioning	Drug: aerosolized 2% lidocaine (20mg/ml); The aerosolized solution to be used is 2% lidocaine (20 mg/ml) at a dose of 1.5 mg/kg with a maximum volume of 3 ml or adjusted to a volume of 3 ml with addition of NS solution.The aerosolized solution will be administered with an Aerogen ultrasonic nebulizer, which is standard of care for administering aerosolized solutions in our pediatric intensive care unit (PICU).After each treatment a 3-minute interval will be allowed prior to ETS and there will be a 4-6 hour wash out period between each treatment.; Drug: instilled 0.9% sodium chloride (NS); The instilled solution will be given with a standard 3-5 ml syringe.After each treatment a 3-minute interval will be allowed prior to ETS and there will be a 4-6 hour wash out period between each treatment.; Drug: instilled 2% lidocaine solution; The instilled 2 % lidocaine solution used will be 1.5 mg/kg, with a max volume of 3 ml or adjusted to a volume of 3 ml with addition of NS solution.The instilled solution will be given with a standard 3-5 ml syringe.After each treatment a 3-minute interval will be allowed prior to ETS and there will be a 4-6 hour wash out period between each treatment.; Procedure: Endotracheal Suctioning (ETS); ETS will be performed in a single pass using a closed-system suctioning. Suction will be applied only on withdrawal of the catheter and fraction of inspired oxygen (FIO2) will remain at 100% for 60 seconds following suctioning and then returned to the preprocedural level (baseline).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum difference between baseline ICP and highest ICP levels as measured by the ICP monitor in instilled lidocaine versus nebulized lidocaine	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.	from baseline to upto 15 minutes after ETS

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum difference between baseline ICP and highest ICP levels as measured by the ICP monitor in nebulized lidocaine and normal saline	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.	from baseline to up to 15 minutes after ETS
Number of patients with worsening respiratory dynamics	This will be measured by increasing oxygenation index or worsening compliance, measured by any increase in the peak pressure for volume ventilated patients.	from baseline to up to 15 minutes after ETS

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Investigators: Principal Investigator: Thao L Nguyen, DO, FAAP, The University of Texas Health Science Center, Houston

Study record dates

Study Major Dates

• Study Start (Actual): November 9, 2021
• Primary Completion (Actual): June 30, 2025
• Study Completion (Actual): June 30, 2025

Study Registration Dates

• First Submitted: September 16, 2021
• First Submitted That Met QC Criteria: September 16, 2021
• First Posted (Actual): September 28, 2021

Study Record Updates

• Last Update Posted (Estimated): January 14, 2026
• Last Update Submitted That Met QC Criteria: January 12, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: lidocaine; intracranial pressure; brain injury
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries, Traumatic; Brain Injuries; Organic Chemicals; Anilides; Amides; Aniline Compounds; Amines; Acetanilides; Inorganic Chemicals; Chlorine Compounds; Sodium Compounds; Chlorides; Hydrochloric Acid; Lidocaine; Sodium Chloride
• Other Study ID Numbers: HSC-MS-21-0254

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No