Incidence of Acute Laryngeal Injury Following Endotracheal Intubation
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|ClinicalTrials.gov Identifier: NCT03250975|
Recruitment Status : Recruiting
First Posted : August 16, 2017
Last Update Posted : January 22, 2020
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.
- Determine the incidence of acute laryngeal injury in patients with prolonged intubation.
- Determine the incidence of chronic laryngeal injury in the subset of patients with acute laryngeal injury
- 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.
|Condition or disease||Intervention/treatment||Phase|
|Intubation Complication||Drug: Budesonide and Azithromycin Other: Placebo control of budesonide and azithromycin||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||64 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Incidence of Acute Laryngeal Injury Following Endotracheal Intubation|
|Actual Study Start Date :||August 19, 2017|
|Estimated Primary Completion Date :||December 30, 2020|
|Estimated Study Completion Date :||December 30, 2021|
Experimental: Medical Therapy
medical therapy group consisting of azithromycin 250 mg and budesonide 0.5 mg for 14 days
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.
Placebo Comparator: Placebo Control
Placebo control medication 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
- Acute Laryngeal Injury [ Time Frame: Within 72 hours of extubation ]Endoscopic examination with evidence of laryngeal injury
- Chronic Obstructive Pulmonary Disease Dyspnea Questionnaire (CCQ) [ Time Frame: 12 week follow up ]12 week patient-reported dyspnea via CCQ. Total score is recorded, with a range of 0-60 with higher values representing worse outcomes.
- Chronic Laryngeal Injury [ Time Frame: 8-12 weeks after sustaining acute laryngeal injury ]In those with acute laryngeal injury, what is the incidence of chronic laryngeal injury
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03250975
|Contact: Justin R Shinn, MD||(406)email@example.com|
|Contact: Anne S Lowery, BAfirstname.lastname@example.org|
|United States, Tennessee|
|Vanderbilt University Medical Center||Recruiting|
|Nashville, Tennessee, United States, 37232|
|Contact: Kate Von Wahlde, MJ, CCRP 615-322-0333 email@example.com|
|Principal Investigator: Alexander Gelbard, MD|
|Sub-Investigator: Justin Shinn, MD|
|Principal Investigator:||Alexander Gelbard, MD||Vanderbilt University Medical Center|