Post-extubation Assessment of Laryngeal Symptoms and Severity

Johns Hopkins University365 enrolled

Overview

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).

Study Type

OBSERVATIONAL

Enrollment

365

Conditions

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

Interventions

laryngoscopyDIAGNOSTIC_TEST

A flexible camera (fiberoptic endoscope) is placed in the patient's nose to view the nose, throat, and airway.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (1)

Johns Hopkins Hospital

Baltimore, Maryland, United States

Outcomes

Primary Outcomes

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).

Time frame: 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).

Time frame: 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).

Time frame: 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).

Time frame: 7 days post-extubation or hospital discharge, whichever occurs first

Secondary Outcomes

Oral endotracheal tube size

Size of the endotracheal tube

Time frame: At the time of intubation (directly following study enrollment)

Duration of orotracheal intubation

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Number of days from placement to extubation of the oral endotracheal tube

Time frame: 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).

Time frame: Within 72 hours post-extubation

Perceptual voice characteristics as assessed by GRBAS method

Time frame: 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

Time frame: Within 72 hours post-extubation

Acoustic voice measurement as assessed by voice analysis software

Time frame: 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).

Time frame: 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

Time frame: 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)

Time frame: 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.

Time frame: 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.

Time frame: Within 90 days of extubation or at ICU discharge, whichever occurs first