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NCT03250975 · ClinicalTrials.gov registry record · Phase 1
Incidence of Acute Laryngeal Injury Following Endotracheal Intubation
A Phase 1 study of Intubation Complication, sponsored by Vanderbilt University Medical Center.
- Active
- Registry status
- Phase 1
- Development phase
- 64
- Enrollment target
- 1
- Study location
NCT03250975 is a Phase 1 study of Intubation Complication that is active but no longer recruiting, run by Vanderbilt University Medical Center. The registered enrollment target is 64 participants, below the 26,547-participant average among 10 other Intubation Complication trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state.
The verdict
NCT03250975, a Phase 1 study of Intubation Complication, is active but no longer recruiting, sponsored by Vanderbilt University Medical Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 64 participants
- Enrollment target
- 1
- Study location
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 |
Interested in This Trial?
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, categorized as Phase 1. The registered enrollment target is 64 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 26,547-participant average among 10 other Intubation Complication trials with a reported enrollment target (100% lower). The listed sponsor is Vanderbilt University Medical Center, which has 677 total studies on file at ClinicalTrials.gov.
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.
NCT03250975 reports 1 study location spanning 1 distinct geographic area - top geographies include Tennessee.
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.
What interventions are being tested in trial NCT03250975?
The interventions under investigation include: Budesonide and Azithromycin (DRUG), Placebo control of budesonide and azithromycin (OTHER).
Who is sponsoring clinical trial NCT03250975?
This trial is sponsored by Vanderbilt University Medical Center, which has 677 total clinical trials registered on ClinicalTrials.gov.
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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Related
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