Trial Outcomes & Findings for Aerosolized Endotracheal Lidocaine to Avoid Intracranial Pressure Spikes in Patients With Severe Traumatic Brain Injury (NCT NCT05058677)

NCT ID: NCT05058677

Last Updated: 2026-08-07

Results Overview

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. ICP Values were recorded at baseline and at 2, 5, and 15 minutes after administration of aerosolized lidocaine, instilled saline solution, or instilled lidocaine solution. Change from baseline is calculated at post intervention time point.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

10 participants

Primary outcome timeframe

Baseline and 2, 5, and 15 minutes post-intervention

Results posted on

2026-08-07

Participant Flow

Participant milestones

Participant milestones
Measure
Aerosolized Lidocaine Then Instilled Lidocaine Solution Then Instilled Saline Solution
Treatment will be performed before the endotracheal suctioning 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). instilled 0.9% sodium chloride (NS): The instilled solution will be given with a standard 3-5 ml syringe. 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. 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).
Aerosolized Lidocaine Then Instilled Saline Solution Then Instilled Lidocaine Solution
Treatment will be performed before the endotracheal suctioning 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). instilled 0.9% sodium chloride (NS): The instilled solution will be given with a standard 3-5 ml syringe. 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. 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).
Instilled Lidocaine Solution Then Aerosolized Lidocaine Then Instilled Saline Solution
Treatment will be performed before the endotracheal suctioning 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). instilled 0.9% sodium chloride (NS): The instilled solution will be given with a standard 3-5 ml syringe. 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. 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).
Instilled Lidocaine Solution Then Instilled Saline Solution Then Aerosolized Lidocaine
Treatment will be performed before the endotracheal suctioning 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). instilled 0.9% sodium chloride (NS): The instilled solution will be given with a standard 3-5 ml syringe. 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. 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).
Instilled Saline Solution Then Aerosolized Lidocaine Then Instilled Lidocaine Solution
Treatment will be performed before the endotracheal suctioning 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). instilled 0.9% sodium chloride (NS): The instilled solution will be given with a standard 3-5 ml syringe. 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. 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).
Instilled Saline Solution Then Instilled Lidocaine Solution Then Aerosolized Lidocaine
Treatment will be performed before the endotracheal suctioning 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). instilled 0.9% sodium chloride (NS): The instilled solution will be given with a standard 3-5 ml syringe. 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. 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).
Overall Study
STARTED
0
0
0
0
0
10
Overall Study
COMPLETED
0
0
0
0
0
0
Overall Study
NOT COMPLETED
0
0
0
0
0
10

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Aerosolized Lidocaine Then Instilled Lidocaine Solution Then Instilled Saline Solution
Treatment will be performed before the endotracheal suctioning 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). instilled 0.9% sodium chloride (NS): The instilled solution will be given with a standard 3-5 ml syringe. 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. 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).
Aerosolized Lidocaine Then Instilled Saline Solution Then Instilled Lidocaine Solution
Treatment will be performed before the endotracheal suctioning 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). instilled 0.9% sodium chloride (NS): The instilled solution will be given with a standard 3-5 ml syringe. 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. 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).
Instilled Lidocaine Solution Then Aerosolized Lidocaine Then Instilled Saline Solution
Treatment will be performed before the endotracheal suctioning 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). instilled 0.9% sodium chloride (NS): The instilled solution will be given with a standard 3-5 ml syringe. 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. 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).
Instilled Lidocaine Solution Then Instilled Saline Solution Then Aerosolized Lidocaine
Treatment will be performed before the endotracheal suctioning 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). instilled 0.9% sodium chloride (NS): The instilled solution will be given with a standard 3-5 ml syringe. 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. 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).
Instilled Saline Solution Then Aerosolized Lidocaine Then Instilled Lidocaine Solution
Treatment will be performed before the endotracheal suctioning 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). instilled 0.9% sodium chloride (NS): The instilled solution will be given with a standard 3-5 ml syringe. 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. 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).
Instilled Saline Solution Then Instilled Lidocaine Solution Then Aerosolized Lidocaine
n=10 Participants
Treatment will be performed before the endotracheal suctioning 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). instilled 0.9% sodium chloride (NS): The instilled solution will be given with a standard 3-5 ml syringe. 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. 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).
Total
n=10 Participants
Total of all reporting groups
Age, Customized
< 1 year
1 Participants
n=10 Participants
1 Participants
n=10 Participants
Age, Customized
≥ 1 year to < 5 years
0 Participants
n=10 Participants
0 Participants
n=10 Participants
Age, Customized
≥5 years to < 10 years
1 Participants
n=10 Participants
1 Participants
n=10 Participants
Age, Customized
≥10 years to < 18 years
8 Participants
n=10 Participants
8 Participants
n=10 Participants
Sex: Female, Male
Female
5 Participants
n=10 Participants
5 Participants
n=10 Participants
Sex: Female, Male
Male
5 Participants
n=10 Participants
5 Participants
n=10 Participants
Race and Ethnicity Not Collected
0 Participants
Race and Ethnicity were not collected from any participant.
Region of Enrollment
United States
10 participants
n=10 Participants
10 participants
n=10 Participants

PRIMARY outcome

Timeframe: Baseline and 2, 5, and 15 minutes post-intervention

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. ICP Values were recorded at baseline and at 2, 5, and 15 minutes after administration of aerosolized lidocaine, instilled saline solution, or instilled lidocaine solution. Change from baseline is calculated at post intervention time point.

Outcome measures

Outcome measures
Measure
Aerosolized Lidocaine
n=10 Participants
Treatment will be performed before the endotracheal suctioning 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. 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).
Instilled Saline Solution
n=10 Participants
Treatment will be performed before the endotracheal suctioning 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. 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).
Instilled Lidocaine Solution
n=10 Participants
Treatment will be performed before the endotracheal suctioning 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. 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).
Change From Baseline Intracranial Pressure (ICP) at 2, 5 and 15 Minutes.
2 minutes
1.1 mmHg
Standard Deviation 2.8
1.6 mmHg
Standard Deviation 2.6
1.9 mmHg
Standard Deviation 2.9
Change From Baseline Intracranial Pressure (ICP) at 2, 5 and 15 Minutes.
5 minutes
0.1 mmHg
Standard Deviation 1.8
1.4 mmHg
Standard Deviation 1.8
1.2 mmHg
Standard Deviation 2.6
Change From Baseline Intracranial Pressure (ICP) at 2, 5 and 15 Minutes.
15 minutes
-0.5 mmHg
Standard Deviation 2.8
1.5 mmHg
Standard Deviation 1.6
1.7 mmHg
Standard Deviation 4.1

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Aerosolized Lidocaine
n=10 Participants
Treatment will be performed before the endotracheal suctioning 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. 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).
Instilled Saline Solution
n=10 Participants
Treatment will be performed before the endotracheal suctioning 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. 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).
Instilled Lidocaine Solution
n=10 Participants
Treatment will be performed before the endotracheal suctioning 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. 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).
Number of Patients With Worsening Respiratory Dynamics
0 Participants
0 Participants
0 Participants

Adverse Events

Aerosolized Lidocaine

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Instilled Saline Solution

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Instilled Lidocaine Solution

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Thao L Nguyen, DO, FAAP

The University of Texas Health Science Center at Houston

Phone: 713-500-6287

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place