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Incidence of Acute Laryngeal Injury Following Endotracheal Intubation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03250975
Recruitment Status : Recruiting
First Posted : August 16, 2017
Last Update Posted : January 22, 2020
Sponsor:
Information provided by (Responsible Party):
Alexander Gelbard, MD, Vanderbilt University Medical Center

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. 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.

Condition or disease Intervention/treatment Phase
Intubation Complication Drug: Budesonide and Azithromycin Other: Placebo control of budesonide and azithromycin Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Diagnostic
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Acute Laryngeal Injury [ Time Frame: Within 72 hours of extubation ]
    Endoscopic examination with evidence of laryngeal injury

  2. 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.


Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Contacts
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Contact: Justin R Shinn, MD (406)531-9698 justin.r.shinn@vanderbilt.edu
Contact: Anne S Lowery, BA 314-373-9228 anne.sun@vanderbilt.edu

Locations
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United States, Tennessee
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37232
Contact: Kate Von Wahlde, MJ, CCRP    615-322-0333    kate.vonwahlde@vanderbilt.edu   
Principal Investigator: Alexander Gelbard, MD         
Sub-Investigator: Justin Shinn, MD         
Sponsors and Collaborators
Vanderbilt University Medical Center
Investigators
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Principal Investigator: Alexander Gelbard, MD Vanderbilt University Medical Center

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Alexander Gelbard, MD, Assistant Professor, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT03250975    
Other Study ID Numbers: 171066
First Posted: August 16, 2017    Key Record Dates
Last Update Posted: January 22, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Alexander Gelbard, MD, Vanderbilt University Medical Center:
Intubation injury
Acute laryngeal injury
Chronic Laryngeal Injury
Additional relevant MeSH terms:
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Wounds and Injuries
Budesonide
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists