Clinical trial
Aerosolized Endotracheal Lidocaine to Avoid Intracranial Pressure Spikes in Patients With Severe Traumatic Brain Injury
Name
HSC-MS-21-0254
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).
Trial arms
Trial start
2021-11-09
Estimated PCD
2024-08-31
Trial end
2024-08-31
Status
Recruiting
Phase
Early phase I
Treatment
aerosolized 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.
Arms:
Instilled lidocaine solution then aerosolized lidocaine then instilled saline solution, Instilled lidocaine solution then instilled saline solution then aerosolized lidocaine, Instilled saline solution then Instilled lidocaine solution then aerosolized lidocaine, Instilled saline solution then aerosolized lidocaine then Instilled lidocaine solution, aerosolized lidocaine then Instilled lidocaine solution then instilled saline solution, aerosolized lidocaine then instilled saline solution then Instilled lidocaine solution
instilled 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.
Arms:
Instilled lidocaine solution then aerosolized lidocaine then instilled saline solution, Instilled lidocaine solution then instilled saline solution then aerosolized lidocaine, Instilled saline solution then Instilled lidocaine solution then aerosolized lidocaine, Instilled saline solution then aerosolized lidocaine then Instilled lidocaine solution, aerosolized lidocaine then Instilled lidocaine solution then instilled saline solution, aerosolized lidocaine then instilled saline solution then Instilled lidocaine solution
instilled 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.
Arms:
Instilled lidocaine solution then aerosolized lidocaine then instilled saline solution, Instilled lidocaine solution then instilled saline solution then aerosolized lidocaine, Instilled saline solution then Instilled lidocaine solution then aerosolized lidocaine, Instilled saline solution then aerosolized lidocaine then Instilled lidocaine solution, aerosolized lidocaine then Instilled lidocaine solution then instilled saline solution, aerosolized lidocaine then instilled saline solution then Instilled lidocaine solution
Endotracheal 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).
Arms:
Instilled lidocaine solution then aerosolized lidocaine then instilled saline solution, Instilled lidocaine solution then instilled saline solution then aerosolized lidocaine, Instilled saline solution then Instilled lidocaine solution then aerosolized lidocaine, Instilled saline solution then aerosolized lidocaine then Instilled lidocaine solution, aerosolized lidocaine then Instilled lidocaine solution then instilled saline solution, aerosolized lidocaine then instilled saline solution then Instilled lidocaine solution
Size
12
Primary endpoint
Maximum difference between baseline ICP and highest ICP levels as measured by the ICP monitor in instilled lidocaine versus nebulized lidocaine
from baseline to upto 15 minutes after ETS
Eligibility 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)
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 12, 'type': 'ESTIMATED'}}
Updated at
2023-11-07
1 organization
3 products
1 indication
Product
2% LidocaineIndication
Traumatic Brain InjuryProduct
Lidocaine 2% Solution