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Incidence of Acute Laryngeal Injury Following Endotracheal Intubation
NCT03250975 · View on ClinicalTrials.gov ↗
Study Summary
The purpose of this investigation is to delineate the incidence of acute and chronic laryngeal injury following intubation within our health system. In addition, this study seeks to identify risk factors for airway injury that may provide information to help reduce the incidence of injury or increase the speed of diagnosis through hospital based process measures. Study Aims 1. Determine the incidence of acute laryngeal injury in patients with prolonged intubation. 2. Determine the incidence of chronic laryngeal injury in the subset of patients with acute laryngeal injury 3. Initiate a randomized control trial to investigate the ability of azithromycin and budesonide to improve objective and subjective breathing measures in patients with Acute Laryngeal injury (ALgI) following endotracheal intubation.
Conditions Studied
Interventions
- DRUG Budesonide and Azithromycin
- OTHER Placebo control of budesonide and azithromycin
Study Locations (1)
Tennessee
- Vanderbilt University Medical Center — Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 64 participants |
| Start Date | 2017-08-19 |
| Est. Completion | 2026-12-30 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03250975
The ClinicalTrials.gov registry entry for NCT03250975 describes a study currently listed as active not recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 64 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Vanderbilt University Medical Center, which has 695 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Intubation Complication appearing as the primary indexed condition, and to 2 interventions — of which Budesonide and Azithromycin is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03250975 reports 1 study location spanning 1 distinct geographic area — top geographies include Tennessee. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT03250975 about?
NCT03250975 is a clinical study titled "Incidence of Acute Laryngeal Injury Following Endotracheal Intubation". The purpose of this investigation is to delineate the incidence of acute and chronic laryngeal injury following intubation within our health system. In addition, this study seeks to identify risk factors for airway injury that may provide information to help reduce the incidence of injury or increas...
What is the current status of trial NCT03250975?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 64 participants. The study started on 2017-08-19. Estimated completion is 2026-12-30.
What conditions does trial NCT03250975 study?
This clinical trial studies the following conditions: Intubation Complication. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03250975?
The interventions under investigation include: Budesonide and Azithromycin (DRUG), Placebo control of budesonide and azithromycin (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03250975?
This trial is sponsored by Vanderbilt University Medical Center, which has 695 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT03250975 being conducted?
This trial has 1 study location across Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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