Status:
ACTIVE_NOT_RECRUITING
Incidence of Acute Laryngeal Injury Following Endotracheal Intubation
Lead Sponsor:
Vanderbilt University Medical Center
Conditions:
Intubation Complication
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
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 fact...
Detailed Description
In the United States, 55 000 patients receive care in more than 6 000 intensive care units (ICUs) each day. The most common reason for ICU admission is respiratory failure and the need for a mechanica...
Eligibility Criteria
Inclusion
- English-speaking
- Greater than 24 hours and less than 7 days of intubation in the intensive care unit
Exclusion
- 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
Key Trial Info
Start Date :
August 19 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2026
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT03250975
Start Date
August 19 2017
End Date
December 30 2026
Last Update
November 3 2025
Active Locations (1)
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1
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232