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

NCT ID: NCT05058677

Last Updated: 2026-01-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-09
• Study Completion Date: 2025-06-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

aerosolized lidocaine then Instilled lidocaine solution then instilled saline solution

Treatment will be performed before the endotracheal suctioning

Group Type: EXPERIMENTAL

aerosolized 2% lidocaine (20mg/ml)

Intervention Type: 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 0.9% sodium chloride (NS)

Intervention Type: 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 2% lidocaine solution

Intervention Type: 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.

Endotracheal Suctioning (ETS)

Intervention Type: 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).

aerosolized lidocaine then instilled saline solution then Instilled lidocaine solution

Treatment will be performed before the endotracheal suctioning

Group Type: EXPERIMENTAL

aerosolized 2% lidocaine (20mg/ml)

Intervention Type: 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 0.9% sodium chloride (NS)

Intervention Type: 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 2% lidocaine solution

Intervention Type: 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.

Endotracheal Suctioning (ETS)

Intervention Type: 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

Treatment will be performed before the endotracheal suctioning

Group Type: EXPERIMENTAL

aerosolized 2% lidocaine (20mg/ml)

Intervention Type: 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 0.9% sodium chloride (NS)

Intervention Type: 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 2% lidocaine solution

Intervention Type: 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.

Endotracheal Suctioning (ETS)

Intervention Type: 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 instilled saline solution then aerosolized lidocaine

Treatment will be performed before the endotracheal suctioning

Group Type: EXPERIMENTAL

aerosolized 2% lidocaine (20mg/ml)

Intervention Type: 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 0.9% sodium chloride (NS)

Intervention Type: 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 2% lidocaine solution

Intervention Type: 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.

Endotracheal Suctioning (ETS)

Intervention Type: 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 saline solution then aerosolized lidocaine then Instilled lidocaine solution

Treatment will be performed before the endotracheal suctioning

Group Type: EXPERIMENTAL

aerosolized 2% lidocaine (20mg/ml)

Intervention Type: 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 0.9% sodium chloride (NS)

Intervention Type: 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 2% lidocaine solution

Intervention Type: 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.

Endotracheal Suctioning (ETS)

Intervention Type: 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 saline solution then Instilled lidocaine solution then aerosolized lidocaine

Treatment will be performed before the endotracheal suctioning

Group Type: EXPERIMENTAL

aerosolized 2% lidocaine (20mg/ml)

Intervention Type: 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 0.9% sodium chloride (NS)

Intervention Type: 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 2% lidocaine solution

Intervention Type: 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.

Endotracheal Suctioning (ETS)

Intervention Type: 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).

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: DRUG

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).

Intervention Type: PROCEDURE

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)

• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The University of Texas Health Science Center, Houston

OTHER

Sponsor Role: lead

Responsible Party

Thao L Nguyen

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Thao L Nguyen, DO, FAAP

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Locations

The University of Texas Health Science Center at Houston

Houston, Texas, United States

Countries

United States

Other Identifiers

HSC-MS-21-0254

Identifier Type: -

Identifier Source: org_study_id