Incidence of Acute Laryngeal Injury Following Endotracheal Intubation (NCT03250975)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (2 items) and avoid the listed exclusions (15 items).
Location: Vanderbilt University Medical Center — Nashville, Tennessee
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- Age under 18 years on admission
- Patients with anticipated discharge 5 days after extubation
- Patients who are dependent for activities of daily living (ADLs) in the 30 days prior to admission
- Patients unable to consent
- Patients with neck trauma
- Patients with head and neck malignancies
- Patients with pre-existing laryngeal or tracheal stenosis
- Patients with other pre-existing respiratory conditions such as chronic obstructive pulmonary disease (COPD), asthma, neuromuscular dystrophies, cystic fibrosis, bronchiectasis
- Patients who had been previously intubated for an extended period of time
- Patients who are pregnant or currently breastfeeding
- Patients with allergies to study medications
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (1 Sites)
- Vanderbilt University Medical Center — Nashville, Tennessee
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Intubation Complication
- CRICKET: Critical Events in Anaesthetised Kids Undergoing Tracheal Intubation — Boston, Massachusetts
- Diagnostic Accuracy of Core Stethoscope Auscultation vs. Point of Care Ultrasound in Placement of Endotracheal Tube — Palo Alto, California
- Smart Checklist Implementation for Pediatric Tracheal Intubations in the ICU- Multicenter Study — Little Rock, Arkansas
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.