Back to results

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

Primary Purpose

Traumatic Brain Injury

Status

Unknown status

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

aerosolized 2% lidocaine (20mg/ml)

instilled 0.9% sodium chloride (NS)

instilled 2% lidocaine solution

Endotracheal Suctioning (ETS)

About this trial

This is an interventional treatment trial for Traumatic Brain Injury focused on measuring lidocaine, brain injury, intracranial pressure

Eligibility Criteria

undefined - 16 Years (Child)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

The University of Texas Health Science Center at Houston

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Arm Label

aerosolized lidocaine then Instilled lidocaine solution then instilled saline solution

aerosolized lidocaine then instilled saline solution then Instilled lidocaine solution

Instilled lidocaine solution then aerosolized lidocaine then instilled saline solution

Instilled lidocaine solution then instilled saline solution then aerosolized lidocaine

Instilled saline solution then aerosolized lidocaine then Instilled lidocaine solution

Instilled saline solution then Instilled lidocaine solution then aerosolized lidocaine

Arm Description

Treatment will be performed before the endotracheal suctioning

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

Full Information

NCT ID

NCT05058677

First Posted

September 16, 2021

Last Updated

October 3, 2021

Sponsor

The University of Texas Health Science Center, Houston

1. Study Identification

Unique Protocol Identification Number

NCT05058677

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2021

Overall Recruitment Status

Unknown status

Study Start Date

October 1, 2021 (Anticipated)

Primary Completion Date

May 31, 2022 (Anticipated)

Study Completion Date

June 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

The University of Texas Health Science Center, Houston

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Traumatic Brain Injury

Keywords

lidocaine, brain injury, intracranial pressure

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

aerosolized lidocaine then Instilled lidocaine solution then instilled saline solution

Arm Type

Experimental

Arm Description

Treatment will be performed before the endotracheal suctioning

Arm Title

aerosolized lidocaine then instilled saline solution then Instilled lidocaine solution

Arm Type

Experimental

Arm Description

Treatment will be performed before the endotracheal suctioning

Arm Title

Instilled lidocaine solution then aerosolized lidocaine then instilled saline solution

Arm Type

Experimental

Arm Description

Treatment will be performed before the endotracheal suctioning

Arm Title

Instilled lidocaine solution then instilled saline solution then aerosolized lidocaine

Arm Type

Experimental

Arm Description

Treatment will be performed before the endotracheal suctioning

Arm Title

Instilled saline solution then aerosolized lidocaine then Instilled lidocaine solution

Arm Type

Experimental

Arm Description

Treatment will be performed before the endotracheal suctioning

Arm Title

Instilled saline solution then Instilled lidocaine solution then aerosolized lidocaine

Arm Type

Experimental

Arm Description

Treatment will be performed before the endotracheal suctioning

Intervention Type

Drug

Intervention Name(s)

aerosolized 2% lidocaine (20mg/ml)

Intervention Description

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

Intervention Name(s)

instilled 0.9% sodium chloride (NS)

Intervention Description

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

Intervention Name(s)

instilled 2% lidocaine solution

Intervention Description

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

Procedure

Intervention Name(s)

Endotracheal Suctioning (ETS)

Intervention Description

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).

Primary Outcome Measure Information:

Title

Maximum difference between baseline ICP and highest ICP levels as measured by the ICP monitor in instilled lidocaine versus nebulized lidocaine

Description

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.

Time Frame

from baseline to upto 15 minutes after ETS

Secondary Outcome Measure Information:

Title

Maximum difference between baseline ICP and highest ICP levels as measured by the ICP monitor in nebulized lidocaine and normal saline

Description

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.

Time Frame

from baseline to up to 15 minutes after ETS

Title

Number of patients with worsening respiratory dynamics

Description

This will be measured by increasing oxygenation index or worsening compliance, measured by any increase in the peak pressure for volume ventilated patients.

Time Frame

from baseline to up to 15 minutes after ETS

10. Eligibility

Sex

All

Maximum Age & Unit of Time

16 Years

Accepts Healthy Volunteers

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)

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Sheikh S Ahmed, MD

Phone

(713) 500-5553

Sheikh.S.Ahmed@uth.tmc.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Viswamitra Ragoonanan, MD

Phone

(713) 500-5650

Viswamitra.Ragoonanan@uth.tmc.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sheikh Ahmed, MD

Organizational Affiliation

The University of Texas Health Science Center, Houston

Official's Role

Principal Investigator

Facility Information:

Facility Name

The University of Texas Health Science Center at Houston

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Sheikh S Ahmed, MD

Phone

713-500-5553

Sheikh.S.Ahmed@uth.tmc.edu

First Name & Middle Initial & Last Name & Degree

Viswamitra Ragoonanan, MD

Phone

(713) 500-5650

Viswamitra.Ragoonanan@uth.tmc.edu

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

We'll reach out to this number within 24 hrs