Clinical trial

Incidence of Acute Laryngeal Injury Following Endotracheal Intubation

Name
171066
Description
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.
Trial arms
Trial start
2017-08-19
Estimated PCD
2024-12-30
Trial end
2025-12-30
Status
Recruiting
Phase
Early phase I
Treatment
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.
Arms:
Medical Therapy
Placebo control of budesonide and azithromycin
placebos of the medications will be given for 14 days in patients randomized to the control group
Arms:
Placebo Control
Size
64
Primary endpoint
Acute Laryngeal Injury
Within 72 hours of extubation
Chronic Obstructive Pulmonary Disease Dyspnea Questionnaire (CCQ)
12 week follow up
Eligibility criteria
Inclusion Criteria: 1. English-speaking 2. Greater than 24 hours and less than 7 days of intubation in the intensive care unit Exclusion Criteria: 1. Age under 18 years on admission 2. Patients with anticipated discharge 5 days after extubation 3. Patients who are dependent for activities of daily living (ADLs) in the 30 days prior to admission 4. Patients unable to consent 5. Patients with neck trauma 6. Patients with head and neck malignancies 7. Patients with pre-existing laryngeal or tracheal stenosis 8. Patients with other pre-existing respiratory conditions such as chronic obstructive pulmonary disease (COPD), asthma, neuromuscular dystrophies, cystic fibrosis, bronchiectasis 9. Patients who had been previously intubated for an extended period of time 10. Patients who are pregnant or currently breastfeeding 11. Patients with allergies to study medications 12. Patients with a resting heart rate greater than 100 beats per minute 13. 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 14. Patients with severe hearing impairment documented by audiometric testing
Protocol
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Updated at
2023-12-19

1 organization

1 product

1 indication