EICHORCondition: Traumatic Brain Injury · Sponsor: The University of Texas Health Science Center, Houston
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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).
This description comes directly from the study's public registry record.
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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)
Reproduced word-for-word from the public registry record — the study team can answer questions about it.
| The University of Texas Health Science Center at Houston | Houston, Texas, United States | — |
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Source record: clinicaltrials.gov/study/NCT05058677