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Completed

NCT Number: NCT03726086

Post-extubation Assessment of Laryngeal Symptoms and Severity

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).

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Key information

Conditions

Intubation, Intratracheal Complication of Ventilation Therapy Critical Illness Disease Attributes Laryngeal Diseases Mechanical Ventilation Complication Otorhinolaryngologic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Tracheal Diseases Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

laryngoscopy

Diagnostic Test

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

Primary outcomes

  1. Laryngeal injury as assessed by 4-point categorical scale

    Time frame: Within 72 hours post-extubation

    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).

  2. Laryngeal injury symptom grading by Laryngeal Hypersensitivity Questionnaire (LHQ)

    Time frame: Within 48 hours of anticipated extubation

    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).

  3. Laryngeal injury symptom grading by LHQ

    Time frame: Within 72 hours post-extubation

    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).

  4. Laryngeal injury symptom grading by LHQ

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

    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).

Secondary outcomes

  1. Oral endotracheal tube size

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

    Size of the endotracheal tube

  2. Duration of orotracheal intubation

    Time frame: From date of intubation to date of extubation or placement of a tracheostomy tube, whichever occurs first, assessed up to 14 days

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

  3. Perceptual voice characteristics as assessed by Grade Rough Breathy Asthenic Strained (GRBAS) method

    Time frame: Within 72 hours post-extubation

    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).

  4. Perceptual voice characteristics as assessed by GRBAS method

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

    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).

  5. Acoustic voice measurement as assessed by voice analysis software

    Time frame: Within 72 hours post-extubation

    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

  6. Acoustic voice measurement as assessed by voice analysis software

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

    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. Patient perception of voice and voice symptoms assessed by the Voice Symptom Scale (VoiSS)

    Time frame: Within 72 hours post-extubation and at 7 days post-extubation or hospital discharge, whichever occurs first

    a 30-item questionnaire that uses scaled scores across 3 domains-impairment (15 items), physical symptoms (8 items), and emotional response (7 items).

  8. Isometric Hand Grip Strength-Dynamometry

    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

    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

  9. Peak tongue strength 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

    Tongue strength, tested using tongue bulb pressure, will be assessed using the Iowa Oral Performance Instrument (IOPI)

  10. Yale Swallow Protocol

    Time frame: Within 72 hours post-extubation

    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.

  11. Function Oral Intake Scale (FOIS)

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

    A 7-point clinical scale to document change in functional oral intake of food and liquid in patients.

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • National Institute of Nursing Research (NINR)

Registry information

Acronym: PALSS

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Oct 31, 2018
Registry last updated
Jul 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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