Incidence of Acute Laryngeal Injury Following Endotracheal Intubation

Running, not enrolling · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Intubation Complication

In brief

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.

Key facts

Study ID

NCT03250975

Run by

Vanderbilt University Medical Center

People needed

64

Starts

2017-08-19

Expected to finish

2026-12-30

Last updated by the study team

2026-06-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• English-speaking
• Greater than 24 hours and less than 7 days of intubation in the intensive care unit

You may not qualify if…

• 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
• Patients with a resting heart rate greater than 100 beats per minute
• Patients with a prolonged corrected QT (QTc) interval (>450 msec) or the use of medications that prolong the QTc interval or are associated with Torsades de pointes (with the exception of amiodarone)24
• Patients with severe hearing impairment documented by audiometric testing

Where it is running

• Vanderbilt University Medical Center — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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