Aerosolized Endotracheal Lidocaine to Avoid Intracranial Pressure Spikes in Patients With Severe Traumatic Brain Injury

Browse trials for

• Brain Injuries, Traumatic 1,775
• Brain Injuries 2,113

Keywords

• lidocaine
• brain injury
• intracranial pressure

Brain Injuries, Traumatic

1,775 studies on the registry are indexed under Brain Injuries, Traumatic; 448 are open to participants now.

This study's enrollment of 10 is below the median of 56 across 1,133 interventional studies indexed under Brain Injuries, Traumatic.

Lead sponsor

The University of Texas Health Science Center, Houston is the lead sponsor of 880 studies on the registry; 209 are open to participants now.

Of its 170 completed or terminated interventional studies of FDA-regulated products, 140 (82%) have results posted.

Study arms

• Experimental
  aerosolized lidocaine then Instilled lidocaine solution then instilled saline solution

  Treatment will be performed before the endotracheal suctioning

  Drug: aerosolized 2% lidocaine (20mg/ml) · Drug: instilled 0.9% sodium chloride (NS) · Drug: instilled 2% lidocaine solution · Procedure: Endotracheal Suctioning (ETS)

• Experimental
  aerosolized lidocaine then instilled saline solution then Instilled lidocaine solution

  Treatment will be performed before the endotracheal suctioning

  Drug: aerosolized 2% lidocaine (20mg/ml) · Drug: instilled 0.9% sodium chloride (NS) · Drug: instilled 2% lidocaine solution · Procedure: Endotracheal Suctioning (ETS)

• Experimental
  Instilled lidocaine solution then aerosolized lidocaine then instilled saline solution

  Treatment will be performed before the endotracheal suctioning

  Drug: aerosolized 2% lidocaine (20mg/ml) · Drug: instilled 0.9% sodium chloride (NS) · Drug: instilled 2% lidocaine solution · Procedure: Endotracheal Suctioning (ETS)

• Experimental
  Instilled lidocaine solution then instilled saline solution then aerosolized lidocaine

  Treatment will be performed before the endotracheal suctioning

  Drug: aerosolized 2% lidocaine (20mg/ml) · Drug: instilled 0.9% sodium chloride (NS) · Drug: instilled 2% lidocaine solution · Procedure: Endotracheal Suctioning (ETS)

• Experimental
  Instilled saline solution then aerosolized lidocaine then Instilled lidocaine solution

  Treatment will be performed before the endotracheal suctioning

  Drug: aerosolized 2% lidocaine (20mg/ml) · Drug: instilled 0.9% sodium chloride (NS) · Drug: instilled 2% lidocaine solution · Procedure: Endotracheal Suctioning (ETS)

• Experimental
  Instilled saline solution then Instilled lidocaine solution then aerosolized lidocaine

  Treatment will be performed before the endotracheal suctioning

  Drug: aerosolized 2% lidocaine (20mg/ml) · Drug: instilled 0.9% sodium chloride (NS) · Drug: instilled 2% lidocaine solution · Procedure: Endotracheal Suctioning (ETS)

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).

Primary outcomes

1. Change From Baseline Intracranial Pressure (ICP) at 2, 5 and 15 Minutes.

   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.

   Time frame: Baseline and 2, 5, and 15 minutes post-intervention

Secondary outcomes

1. Number of Patients With Worsening Respiratory Dynamics

   This will be measured by increasing oxygenation index or worsening compliance, measured by any increase in the peak pressure for volume ventilated patients.

   Time frame: from baseline to up to 15 minutes after ETS

Baseline characteristics

Study documents

• Protocol and statistical analysis plan · Sep 7, 2021

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No