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ACTIVE NOT RECRUITING
NCT03250975
PHASE1/PHASE2

Incidence of Acute Laryngeal Injury Following Endotracheal Intubation

Sponsor: Vanderbilt University Medical Center

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

64

Start Date

2017-08-19

Completion Date

2026-12-30

Last Updated

2025-11-03

Healthy Volunteers

No

Interventions

DRUG

Budesonide and Azithromycin

Participant with acute laryngeal injury will be randomized at discharge to either a non-drug placebo control group or a medical therapy group consisting of azithromycin 250 mg and budesonide 0.5 mg for 14 days.

OTHER

Placebo control of budesonide and azithromycin

placebos of the medications will be given for 14 days in patients randomized to the control group

Locations (1)

Vanderbilt University Medical Center

Nashville, Tennessee, United States