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

NCT05058677 | Completed Phase 4 FDA Drug

• 1 other identifier: HSC-MS-21-0254
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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).

Conditions

Traumatic Brain Injury

Keywords

lidocaine; brain injury; intracranial pressure

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

• Number of patients with worsening respiratory dynamics

  from baseline to up to 15 minutes after ETS

Study Arms (6)

aerosolized lidocaine then Instilled lidocaine solution then instilled saline solution

EXPERIMENTAL

Treatment will be performed before the endotracheal suctioning

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

aerosolized lidocaine then instilled saline solution then Instilled lidocaine solution

EXPERIMENTAL

Treatment will be performed before the endotracheal suctioning

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

Instilled lidocaine solution then aerosolized lidocaine then instilled saline solution

EXPERIMENTAL

Treatment will be performed before the endotracheal suctioning

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

Instilled lidocaine solution then instilled saline solution then aerosolized lidocaine

EXPERIMENTAL

Treatment will be performed before the endotracheal suctioning

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

Instilled saline solution then aerosolized lidocaine then Instilled lidocaine solution

EXPERIMENTAL

Treatment will be performed before the endotracheal suctioning

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

Instilled saline solution then Instilled lidocaine solution then aerosolized lidocaine

EXPERIMENTAL

Treatment will be performed before the endotracheal suctioning

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

Interventions

instilled 2% lidocaine solution DRUG

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.

Instilled lidocaine solution then aerosolized lidocaine then instilled saline solution; Instilled lidocaine solution then instilled saline solution then aerosolized lidocaine; Instilled saline solution then Instilled lidocaine solution then aerosolized lidocaine; Instilled saline solution then aerosolized lidocaine then Instilled lidocaine solution; aerosolized lidocaine then Instilled lidocaine solution then instilled saline solution; aerosolized lidocaine then instilled saline solution then Instilled lidocaine solution

Endotracheal Suctioning (ETS) PROCEDURE

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).

Instilled lidocaine solution then aerosolized lidocaine then instilled saline solution; Instilled lidocaine solution then instilled saline solution then aerosolized lidocaine; Instilled saline solution then Instilled lidocaine solution then aerosolized lidocaine; Instilled saline solution then aerosolized lidocaine then Instilled lidocaine solution; aerosolized lidocaine then Instilled lidocaine solution then instilled saline solution; aerosolized lidocaine then instilled saline solution then Instilled lidocaine solution

aerosolized 2% lidocaine (20mg/ml) DRUG

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.

Instilled lidocaine solution then aerosolized lidocaine then instilled saline solution; Instilled lidocaine solution then instilled saline solution then aerosolized lidocaine; Instilled saline solution then Instilled lidocaine solution then aerosolized lidocaine; Instilled saline solution then aerosolized lidocaine then Instilled lidocaine solution; aerosolized lidocaine then Instilled lidocaine solution then instilled saline solution; aerosolized lidocaine then instilled saline solution then Instilled lidocaine solution

instilled 0.9% sodium chloride (NS) DRUG

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.

Instilled lidocaine solution then aerosolized lidocaine then instilled saline solution; Instilled lidocaine solution then instilled saline solution then aerosolized lidocaine; Instilled saline solution then Instilled lidocaine solution then aerosolized lidocaine; Instilled saline solution then aerosolized lidocaine then Instilled lidocaine solution; aerosolized lidocaine then Instilled lidocaine solution then instilled saline solution; aerosolized lidocaine then instilled saline solution then Instilled lidocaine solution

Eligibility Criteria

• Age: Up to 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

• 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)

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic; Brain Injuries

Interventions

Lidocaine; Sodium Chloride

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Thao L Nguyen, DO, FAAP

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 16, 2021
• First Posted: September 28, 2021
• Study Start: November 9, 2021
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: January 14, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)