Traumatic Brain Injury
Conditions
Keywords
lidocaine, brain injury, intracranial pressure
Brief 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).
Interventions
DRUGaerosolized 2% lidocaine (20mg/ml)
The aerosolized solution to be used is 2% lidocaine (20 mg/ml) at a dose of 1.5 mg/kg with a maximum volume of 3 ml or adjusted to a volume of 3 ml with addition of NS solution.The aerosolized solution will be administered with an Aerogen ultrasonic nebulizer, which is standard of care for administering aerosolized solutions in our pediatric intensive care unit (PICU).After each treatment a 3-minute interval will be allowed prior to ETS and there will be a 4-6 hour wash out period between each treatment.
DRUGinstilled 0.9% sodium chloride (NS)
The instilled solution will be given with a standard 3-5 ml syringe.After each treatment a 3-minute interval will be allowed prior to ETS and there will be a 4-6 hour wash out period between each treatment.
DRUGinstilled 2% lidocaine solution
The instilled 2 % lidocaine solution used will be 1.5 mg/kg, with a max volume of 3 ml or adjusted to a volume of 3 ml with addition of NS solution.The instilled solution will be given with a standard 3-5 ml syringe.After each treatment a 3-minute interval will be allowed prior to ETS and there will be a 4-6 hour wash out period between each treatment.
PROCEDUREEndotracheal Suctioning (ETS)
ETS will be performed in a single pass using a closed-system suctioning. Suction will be applied only on withdrawal of the catheter and fraction of inspired oxygen (FIO2) will remain at 100% for 60 seconds following suctioning and then returned to the preprocedural level (baseline).
Sponsors
The University of Texas Health Science Center, Houston
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 16 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline Intracranial Pressure (ICP) at 2, 5 and 15 Minutes. | Baseline and 2, 5, and 15 minutes post-intervention | A Codman Intraparenchymal Catheter will measure the ICP. The ICP will be transduced and measured numerically and continuously in real time on the patient's bedside monitor. ICP Values were recorded at baseline and at 2, 5, and 15 minutes after administration of aerosolized lidocaine, instilled saline solution, or instilled lidocaine solution. Change from baseline is calculated at post intervention time point. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With Worsening Respiratory Dynamics | from baseline to up to 15 minutes after ETS | This will be measured by increasing oxygenation index or worsening compliance, measured by any increase in the peak pressure for volume ventilated patients. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORThao L Nguyen, DO, FAAP
The University of Texas Health Science Center, Houston
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Customized ≥10 years to < 18 years | 8 Participants |
| Age, Customized < 1 year | 1 Participants |
| Age, Customized ≥ 1 year to < 5 years | 0 Participants |
| Age, Customized ≥5 years to < 10 years | 1 Participants |
| Race and Ethnicity Not Collected | 0 Participants |
| Region of Enrollment United States | 10 participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 10 | 0 / 10 |
| other Total, other adverse events | 0 / 10 | 0 / 10 | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 | 0 / 10 |
Outcome results
None listed