Post-extubation Assessment of Laryngeal Symptoms and Severity

Study Overview
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Brief Summary
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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).

Official Title
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Post-extubation Assessment of Laryngeal Symptoms and Severity

Conditions
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Intubation, Intratracheal, Critical Illness, Mechanical Ventilation Complication, Complication of Ventilation Therapy

Intervention / Treatment
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* Diagnostic Test: laryngoscopy


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: laryngoscopy|A flexible camera (fiberoptic endoscope) is placed in the patient's nose to view the nose, throat, and airway.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Laryngeal injury as assessed by 4-point categorical scale | Characterize injuries to the larynx and surrounding tissues/anatomy after mechanical ventilation is no longer required and the oral endotracheal tube is removed. Injuries will be graded on a 4-point categorical scale ranging from 0 (no injury) to 3 (severe injury). | Within 72 hours post-extubation | 
| Laryngeal injury symptom grading by Laryngeal Hypersensitivity Questionnaire (LHQ) | Characterize patient symptoms of laryngeal injury within 48 hours of anticipated extubation. Symptoms will be assessed using a 4-point ordinal scale based on the LHQ, ranging from 1 (all of the time) to 4 (none of the time). | Within 48 hours of anticipated extubation | 
| Laryngeal injury symptom grading by LHQ | Characterize patient symptoms of laryngeal injury within 72 hours post-extubation. Symptoms will be assessed using a 4-point ordinal scale based on the LHQ, ranging from 1 (all of the time) to 4 (none of the time). | Within 72 hours post-extubation | 
| Laryngeal injury symptom grading by LHQ | Characterize patient symptoms of laryngeal injury at 7 days post-extubation or at discharge whichever comes first. Symptoms will be assessed using a 4-point ordinal scale based on the LHQ, ranging from 1 (all of the time) to 4 (none of the time). | 7 days post-extubation or hospital discharge, whichever occurs first | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oral endotracheal tube size | Size of the endotracheal tube | At the time of intubation (directly following study enrollment) | 
| Duration of orotracheal intubation | Number of days from placement to extubation of the oral endotracheal tube | From date of intubation to date of extubation or placement of a tracheostomy tube, whichever occurs first, assessed up to 14 days | 
| Perceptual voice characteristics as assessed by Grade Rough Breathy Asthenic Strained (GRBAS) method | Assessed from standardized voice samples and digital recordings using the grade, rough, breathy, asthenic, and strained (GRBAS) method with a 4-point ordinal scale ranging from 0 (normal) to 3 (severe). | Within 72 hours post-extubation | 
| Perceptual voice characteristics as assessed by GRBAS method | Assessed from standardized voice samples and digital recordings using the grade, rough, breathy, asthenic, and strained (GRBAS) method with a 4-point ordinal scale ranging from 0 (normal) to 3 (severe). | 7 days post-extubation or hospital discharge, whichever occurs first | 
| Acoustic voice measurement as assessed by voice analysis software | Assessed from standardized voice samples and digital recordings using the Computerized Speech Lab (PENTAX Medical) with voice analysis software (viz., Multi-Dimensional Voice Program (MDVP); Analysis of Dysphonia in Speech and Voice (ADSV)) to quantify voice characteristics across a number of parameters | Within 72 hours post-extubation | 
| Acoustic voice measurement as assessed by voice analysis software | Assessed from standardized voice samples and digital recordings using the Computerized Speech Lab (PENTAX Medical) with voice analysis software (viz., Multi-Dimensional Voice Program (MDVP); Analysis of Dysphonia in Speech and Voice (ADSV)) to quantify voice characteristics across a number of parameters. | 7 days post-extubation or hospital discharge, whichever occurs first | 
| Patient perception of voice and voice symptoms assessed by the Voice Symptom Scale (VoiSS) | a 30-item questionnaire that uses scaled scores across 3 domains-impairment (15 items), physical symptoms (8 items), and emotional response (7 items). | Within 72 hours post-extubation and at 7 days post-extubation or hospital discharge, whichever occurs first | 
| Isometric Hand Grip Strength-Dynamometry | Grip strength provides a measure of distal muscle strength that has important functional application for patients. Grip strength, tested by hand grip dynamometry, will be assessed in each hand using a Jamar Preston hand dynamometer | Within 48 hours of anticipated extubation, within 72 hours post-extubation, and at 7 days post-extubation or hospital discharge, whichever occurs first | 
| Peak tongue strength assessed using the Iowa Oral Performance Instrument (IOPI) | Tongue strength, tested using tongue bulb pressure, will be assessed using the Iowa Oral Performance Instrument (IOPI) | Within 48 hours of anticipated extubation, within 72 hours post-extubation, and at 7 days post-extubation or hospital discharge, whichever occurs first | 
| Yale Swallow Protocol | A cognitive screen and administration of a cup containing 3 oz. (90 ml) of water handed to the patient for uninterrupted continuous consumption via cup or straw. Interrupted consumption (i.e., stopping, resting), and/or coughing, choking, throat clearing, or a change in vocal quality (i.e., a wet, gurgly quality after consumption is completed) signifies a failed screening. | Within 72 hours post-extubation | 
| Function Oral Intake Scale (FOIS) | A 7-point clinical scale to document change in functional oral intake of food and liquid in patients. | Within 90 days of extubation or at ICU discharge, whichever occurs first | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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larynx, injury, voice, trachea