Incidence of Acute Laryngeal Injury Following Endotracheal Intubation

NCT03250975 | Active Not Recruiting Phase 1 FDA Drug

• 1 other identifier: 171066
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief 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. 1.Determine the incidence of acute laryngeal injury in patients with prolonged intubation.
2. 2.Determine the incidence of chronic laryngeal injury in the subset of patients with acute laryngeal injury
3. 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.

Conditions

Intubation Complication

Keywords

Intubation injury; Acute laryngeal injury; Chronic Laryngeal Injury

Outcome Measures

Primary Outcomes (2)

• Acute Laryngeal Injury

  Endoscopic examination with evidence of laryngeal injury

  Within 72 hours of extubation

• Chronic Obstructive Pulmonary Disease Dyspnea Questionnaire (CCQ)

  12 week patient-reported dyspnea via CCQ. Total score is recorded, with a range of 0-60 with higher values representing worse outcomes.

  12 week follow up

Secondary Outcomes (1)

• Chronic Laryngeal Injury

  8-12 weeks after sustaining acute laryngeal injury

Study Arms (2)

Medical Therapy

EXPERIMENTAL

medical therapy group consisting of azithromycin 250 mg and budesonide 0.5 mg for 14 days

Drug: Budesonide and Azithromycin

Placebo Control

PLACEBO COMPARATOR

Placebo control medication for 14 days

Other: Placebo control of budesonide and azithromycin

Interventions

Budesonide and Azithromycin DRUG

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.

Medical Therapy

Placebo control of budesonide and azithromycin OTHER

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

Placebo Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Related Publications (7)

• Angus DC, Linde-Zwirble WT, Lidicker J, Clermont G, Carcillo J, Pinsky MR. Epidemiology of severe sepsis in the United States: analysis of incidence, outcome, and associated costs of care. Crit Care Med. 2001 Jul;29(7):1303-10. doi: 10.1097/00003246-200107000-00002.

  PMID: 11445675 BACKGROUND

• Hillel AT, Karatayli-Ozgursoy S, Samad I, Best SR, Pandian V, Giraldez L, Gross J, Wootten C, Gelbard A, Akst LM, Johns MM; North American Airway Collaborative (NoAAC). Predictors of Posterior Glottic Stenosis: A Multi-Institutional Case-Control Study. Ann Otol Rhinol Laryngol. 2016 Mar;125(3):257-63. doi: 10.1177/0003489415608867. Epub 2015 Oct 14.

  PMID: 26466860 BACKGROUND

• Gelbard A, Francis DO, Sandulache VC, Simmons JC, Donovan DT, Ongkasuwan J. Causes and consequences of adult laryngotracheal stenosis. Laryngoscope. 2015 May;125(5):1137-43. doi: 10.1002/lary.24956. Epub 2014 Oct 7.

  PMID: 25290987 BACKGROUND

• Shinn JR, Campbell BR, Ely EW, Gelbard A. The authors reply. Crit Care Med. 2020 May;48(5):e431. doi: 10.1097/CCM.0000000000004301. No abstract available.

  PMID: 32301783 DERIVED

• Shinn JR, Campbell BR, Ely EW, Gelbard A. The authors reply. Crit Care Med. 2020 Apr;48(4):e338-e339. doi: 10.1097/CCM.0000000000004253. No abstract available.

  PMID: 32205633 DERIVED

• Shinn JR, Kimura KS, Campbell BR, Sun Lowery A, Wootten CT, Garrett CG, Francis DO, Hillel AT, Du L, Casey JD, Ely EW, Gelbard A. Incidence and Outcomes of Acute Laryngeal Injury After Prolonged Mechanical Ventilation. Crit Care Med. 2019 Dec;47(12):1699-1706. doi: 10.1097/CCM.0000000000004015.

  PMID: 31634236 DERIVED

• Lowery AS, Kimura K, Shinn J, Shannon C, Gelbard A. Early medical therapy for acute laryngeal injury (ALgI) following endotracheal intubation: a protocol for a prospective single-centre randomised controlled trial. BMJ Open. 2019 Jul 27;9(7):e027963. doi: 10.1136/bmjopen-2018-027963.

  PMID: 31352415 DERIVED

MeSH Terms

Interventions

Budesonide; Azithromycin

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Erythromycin; Macrolides; Polyketides; Lactones; Organic Chemicals

Study Officials

• Alexander Gelbard, MD

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 7, 2017
• First Posted: August 16, 2017
• Study Start: August 19, 2017
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: November 3, 2025

Record last verified: 2025-10

Locations

US (1)