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NCT05058677 · ClinicalTrials.gov registry record · Phase 4
Aerosolized Endotracheal Lidocaine to Avoid Intracranial Pressure Spikes in Patients With Severe Traumatic Brain Injury
A Phase 4 study, sponsored by The University of Texas Health Science Center, Houston.
- Completed
- Registry status
- Phase 4
- Development phase
- 10
- Enrollment target
NCT05058677: Completed Phase 4 study, sponsored by The University of Texas Health Science Center, Houston.
NCT05058677 is a Phase 4 study that has completed, run by The University of Texas Health Science Center, Houston. The registered enrollment target is 10 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05058677, a Phase 4 study, has completed, sponsored by The University of Texas Health Science Center, Houston.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 10 participants
- Enrollment target
Study 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).
Primary Outcome
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.
Interventions
- DRUG aerosolized 2% lidocaine (20mg/ml)
- DRUG instilled 0.9% sodium chloride (NS)
- DRUG instilled 2% lidocaine solution
- PROCEDURE Endotracheal Suctioning (ETS)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2021-11-09 |
| Est. Completion | 2025-06-30 |
| Phase | Phase 4 |
What the finished NCT05058677 record still lists
NCT05058677 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 4 interventions - of which aerosolized 2% lidocaine (20mg/ml) is the first listed.
NCT05058677 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05058677 about?
NCT05058677 is a clinical study titled "Aerosolized Endotracheal Lidocaine to Avoid Intracranial Pressure Spikes in Patients With Severe Traumatic Brain Injury". 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) i...
What is the current status of trial NCT05058677?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 10 participants. The study started on 2021-11-09. Estimated completion is 2025-06-30.
What interventions are being tested in trial NCT05058677?
The interventions under investigation include: aerosolized 2% lidocaine (20mg/ml) (DRUG), instilled 0.9% sodium chloride (NS) (DRUG), instilled 2% lidocaine solution (DRUG), Endotracheal Suctioning (ETS) (PROCEDURE).
Who is sponsoring clinical trial NCT05058677?
This trial is sponsored by The University of Texas Health Science Center, Houston, which has 732 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05058677's enrollment target sits among peer trials
10 1940th of 2000 higher than 33 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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