Traumatic Brain InjuryPhase 4NCT05058677
Aerosolized Endotracheal Lidocaine to Avoid Intracranial Pressure Spikes in Patients With Severe Traumatic Brain Injury
A Phase 4 study testing aerosolized 2% lidocaine (20mg/ml), instilled 0.9% sodium chloride (NS) and instilled 2% lidocaine solution in people with Traumatic Brain Injury, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages Up to 16 years
- Conditions the study is for
- Traumatic Brain Injury
- What is being tested?
- aerosolized 2% lidocaine (20mg/ml), instilled 0.9% sodium chloride (NS) and instilled 2% lidocaine solution
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Nov 2021to 30 Jun 2025
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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).
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
About this study
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).
- Conditions
- Traumatic Brain Injury
- Being tested
- aerosolized 2% lidocaine (20mg/ml), instilled 0.9% sodium chloride (NS), instilled 2% lidocaine solution, Endotracheal Suctioning (ETS)
- Keywords
- lidocaine, brain injury, intracranial pressure
- Medical subject headings
- Brain Injuries, Traumatic, Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aerosolized 2% lidocaine (20mg/ml)Drug
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.
instilled 0.9% sodium chloride (NS)Drug
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.
instilled 2% lidocaine solutionDrug
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.
Endotracheal Suctioning (ETS)Procedure or surgery
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).
| Study group | Role | What they receive |
|---|---|---|
| aerosolized lidocaine then Instilled lidocaine solution then instilled saline solution | Experimental | Treatment will be performed before the endotracheal suctioning Receives: Drug: aerosolized 2% lidocaine (20mg/ml); Drug: instilled 0.9% sodium chloride (NS); Drug: instilled 2% lidocaine solution; Procedure: Endotracheal Suctioning (ETS) |
| aerosolized lidocaine then instilled saline solution then Instilled lidocaine solution | Experimental | Treatment will be performed before the endotracheal suctioning Receives: Drug: aerosolized 2% lidocaine (20mg/ml); Drug: instilled 0.9% sodium chloride (NS); Drug: instilled 2% lidocaine solution; Procedure: Endotracheal Suctioning (ETS) |
| Instilled lidocaine solution then aerosolized lidocaine then instilled saline solution | Experimental | Treatment will be performed before the endotracheal suctioning Receives: Drug: aerosolized 2% lidocaine (20mg/ml); Drug: instilled 0.9% sodium chloride (NS); Drug: instilled 2% lidocaine solution; Procedure: Endotracheal Suctioning (ETS) |
| Instilled lidocaine solution then instilled saline solution then aerosolized lidocaine | Experimental | Treatment will be performed before the endotracheal suctioning Receives: Drug: aerosolized 2% lidocaine (20mg/ml); Drug: instilled 0.9% sodium chloride (NS); Drug: instilled 2% lidocaine solution; Procedure: Endotracheal Suctioning (ETS) |
| Instilled saline solution then aerosolized lidocaine then Instilled lidocaine solution | Experimental | Treatment will be performed before the endotracheal suctioning Receives: Drug: aerosolized 2% lidocaine (20mg/ml); Drug: instilled 0.9% sodium chloride (NS); Drug: instilled 2% lidocaine solution; Procedure: Endotracheal Suctioning (ETS) |
| Instilled saline solution then Instilled lidocaine solution then aerosolized lidocaine | Experimental | Treatment will be performed before the endotracheal suctioning Receives: Drug: aerosolized 2% lidocaine (20mg/ml); Drug: instilled 0.9% sodium chloride (NS); Drug: instilled 2% lidocaine solution; Procedure: Endotracheal Suctioning (ETS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: from baseline to up to 15 minutes after ETS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2021
- Study start9 Nov 2021
- Primary completion30 Jun 2025
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Texas Health Science Center, Houston
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thao L Nguyen, The University of Texas Health Science Center, Houston
- Investigators
- Thao L Nguyen, DO, FAAP, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05058677
- Sponsor's protocol ID
- HSC-MS-21-0254
- Status last verified
- Jan 2026
- First submitted
- 16 Sep 2021
- Last updated
- 7 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No