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

Last updated: December 4, 2024
Sponsor: The University of Texas Health Science Center, Houston
Overall Status: Active - Recruiting

Phase

4

Condition

Traumatic Brain Injury

Memory Loss

Neurologic Disorders

Treatment

instilled 2% lidocaine solution

instilled 0.9% sodium chloride (NS)

Endotracheal Suctioning (ETS)

Clinical Study ID

NCT05058677
HSC-MS-21-0254
  • Ages < 16
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

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. Wewill not exclude patients with norepinephrine to maintain goal blood pressures tomaintain Cerebral perfusion pressure(CPP).

Exclusion

Exclusion Criteria:

  • Patients with sustained ICP > 25 for more than 30 minutes mm Hg despite medical orneurosurgical 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 andseptic)

Study Design

Total Participants: 12
Treatment Group(s): 4
Primary Treatment: instilled 2% lidocaine solution
Phase: 4
Study Start date:
November 09, 2021
Estimated Completion Date:
June 30, 2025

Connect with a study center

  • The University of Texas Health Science Center at Houston

    Houston, Texas 77030
    United States

    Active - Recruiting

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