Clinical trial NCT03726086: Post-extubation Assessment of Laryngeal Symptoms and Severity
Official title: Post-extubation Assessment of Laryngeal Symptoms and Severity
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intubation, Intratracheal
Critical Illness
Mechanical Ventilation Complication
Complication of Ventilation Therapy
Keywords: larynx
injury
voice
trachea
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2018-10-31
Enrollment: 365
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients admitted to the intensive care unit (ICU) who are orally intubated with mechanical ventilaton meeting inclusion/exclusion criteria

Brief summary: The goal of this study is to learn more about voice and airway problems that patients experience during and after the time patients have an oral endotracheal tube in patients' airway to help patients breathe while receiving mechanical ventilation in an intensive care unit (ICU).


Eligibility criteria: Inclusion Criteria:

* ≥18 years old
* Required mechanical ventilation via an oral endotracheal tube
* Anticipated intubation ≥8 hours

Exclusion Criteria:

* Pre-existing dysphonia, dysphagia
* Pre-existing central nervous system, neuromuscular, or connective tissue disease
* Prior tracheotomy and/or tracheotomy placed prior to enrollment
* History of major thoracic surgery (e.g., sternotomy, thoracotomy) prior to the current admission
* Head and/or neck disease
* Head and/or neck surgery other than tonsillectomy
* Known or suspected anatomical abnormalities or pre-intubation trauma of the oral cavity, pharynx, larynx, or esophagus
* Unlikely to be extubated (i.e., expected death)

Primary outcomes:
measure: Laryngeal injury as assessed by 4-point categorical scale
timeFrame: Within 72 hours post-extubation
measure: Laryngeal injury symptom grading by Laryngeal Hypersensitivity Questionnaire (LHQ)
timeFrame: Within 48 hours of anticipated extubation
measure: Laryngeal injury symptom grading by LHQ
timeFrame: Within 72 hours post-extubation
measure: Laryngeal injury symptom grading by LHQ
timeFrame: 7 days post-extubation or hospital discharge, whichever occurs first
Secondary outcomes:
measure: Oral endotracheal tube size
timeFrame: At the time of intubation (directly following study enrollment)
measure: Duration of orotracheal intubation
timeFrame: From date of intubation to date of extubation or placement of a tracheostomy tube, whichever occurs first, assessed up to 14 days
measure: Perceptual voice characteristics as assessed by Grade Rough Breathy Asthenic Strained (GRBAS) method
timeFrame: Within 72 hours post-extubation
measure: Perceptual voice characteristics as assessed by GRBAS method
timeFrame: 7 days post-extubation or hospital discharge, whichever occurs first
measure: Acoustic voice measurement as assessed by voice analysis software
timeFrame: Within 72 hours post-extubation
measure: Acoustic voice measurement as assessed by voice analysis software
timeFrame: 7 days post-extubation or hospital discharge, whichever occurs first
measure: Patient perception of voice and voice symptoms assessed by the Voice Symptom Scale (VoiSS)
timeFrame: Within 72 hours post-extubation and at 7 days post-extubation or hospital discharge, whichever occurs first
measure: Isometric Hand Grip Strength-Dynamometry
timeFrame: Within 48 hours of anticipated extubation, within 72 hours post-extubation, and at 7 days post-extubation or hospital discharge, whichever occurs first
measure: Peak tongue strength assessed using the Iowa Oral Performance Instrument (IOPI)
timeFrame: Within 48 hours of anticipated extubation, within 72 hours post-extubation, and at 7 days post-extubation or hospital discharge, whichever occurs first
measure: Yale Swallow Protocol
timeFrame: Within 72 hours post-extubation
measure: Function Oral Intake Scale (FOIS)
timeFrame: Within 90 days of extubation or at ICU discharge, whichever occurs first
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Dale M. Needham, MD, PhD
role: PRINCIPAL_INVESTIGATOR
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