RECRUITING

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

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Conditions

Traumatic Brain Injurylidocainebrain injuryintracranial pressure

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

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

Quick Facts

Study Start:2021-11-09
Study Completion:2025-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05058677

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:Not specified to 16 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * Patients admitted to the PICU of Memorial Hermann Children's Hospital
  2. * Severe TBI with a Glasgow Coma Scale score 4-8
  3. * Intubated and mechanically ventilated with an ICP monitor in place.
  4. * Continuous invasive monitoring of arterial pressure
  5. * 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).
  1. * Patients with sustained ICP \> 25 for more than 30 minutes mm Hg despite medical or neurosurgical intervention
  2. * Moderate/Severe Acute respiratory distress syndrome (ARDS) with an oxygenation index \> 8
  3. * Pulmonary hemorrhage
  4. * Patients receiving neuromuscular blockade
  5. * Use of other vasopressors for other causes of shock (cardiogenic, hypovolemic and septic)

Contacts and Locations

Study Contact

Thao L Nguyen, DO, FAAP
CONTACT
(713) 500-6287
Thao.L.Nguyen@uth.tmc.edu
Nikita Tripathi, MD
CONTACT
(713) 500-5652
nikita.tripathi@uth.tmc.edu

Principal Investigator

Thao L Nguyen, DO, FAAP
PRINCIPAL_INVESTIGATOR
The University of Texas Health Science Center, Houston

Study Locations (Sites)

The University of Texas Health Science Center at Houston
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: The University of Texas Health Science Center, Houston

  • Thao L Nguyen, DO, FAAP, PRINCIPAL_INVESTIGATOR, The University of Texas Health Science Center, Houston

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-11-09
Study Completion Date2025-06-30

Study Record Updates

Study Start Date2021-11-09
Study Completion Date2025-06-30

Terms related to this study

Keywords Provided by Researchers

  • lidocaine
  • brain injury
  • intracranial pressure

Additional Relevant MeSH Terms

  • Traumatic Brain Injury