Using aerosolized lidocaine to manage intracranial pressure in severe brain injury patients
Official title: Aerosolized Endotracheal Lidocaine to Avoid Intracranial Pressure Spikes in Patients With Severe Traumatic Brain Injury
Run by The University of Texas Health Science Center, Houston · NCT05058677 · Data updated 2026-05-14
This study is no longer in our active list. It may have stopped recruiting or finished. The details below are as of 2026-05-14 and are kept for reference. Check ClinicalTrials.gov for its current status, or see similar studies below.
This study is testing if using a mist of lidocaine can help lower pressure in the brain during suctioning procedures for children with severe brain injuries.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | Any age to 16 Years |
| Sex | All |
| Enrollment | 12 (estimated) |
| Sponsor | The University of Texas Health Science Center, Houston Academic / other |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT05058677 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are children with severe traumatic brain injury, intubated and mechanically ventilated, and monitored for intracranial pressure.
✕Probably not a fit
Patients with sustained high intracranial pressure or severe respiratory distress syndrome may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study evaluates the effectiveness of nebulized lidocaine compared to instilled lidocaine and normal saline before endotracheal suctioning in children with severe traumatic brain injury. It aims to determine if aerosolized lidocaine can reduce spikes in intracranial pressure during suctioning procedures. The study also assesses the feasibility and safety of using nebulized lidocaine in this patient population. Participants will be closely monitored for hemodynamic stability and intracranial pressure changes.
Why it matters
Potential benefit: If successful, this approach could significantly improve the management of intracranial pressure in children with severe traumatic brain injury.
How similar studies have gone: While similar approaches have been explored, this specific use of aerosolized lidocaine in this context is novel and has not been extensively tested.
Who can join: the full rules
Show full inclusion / exclusion 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)
Where it's running
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The University of Texas Health Science Center at Houston
Houston, Texas, United States Recruiting
Study contacts
- Principal investigator: Thao L Nguyen, DO, FAAP — The University of Texas Health Science Center, Houston
- Study coordinator: Thao L Nguyen, DO, FAAP
- Email: Thao.L.Nguyen@uth.tmc.edu
- Phone: (713) 500-6287
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.