Using aerosolized lidocaine to manage intracranial pressure in severe brain injury patients
Aerosolized Endotracheal Lidocaine to Avoid Intracranial Pressure Spikes in Patients With Severe Traumatic Brain Injury
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 |
| Enrollment | 12 (estimated) |
| Ages | N/A to 16 Years |
| Sex | All |
| Sponsor | The University of Texas Health Science Center, Houston Academic / other |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT05058677 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are children with severe traumatic brain injury, intubated and mechanically ventilated, and monitored for intracranial pressure.
Not a fit: Patients with sustained high intracranial pressure or severe respiratory distress syndrome may not benefit from this study.
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 performed: While similar approaches have been explored, this specific use of aerosolized lidocaine in this context is novel and has not been extensively tested.
Eligibility criteria
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 this trial is running
Houston, Texas
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.