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Post-extubation Assessment of Laryngeal Symptoms and Severity (PALSS)

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ClinicalTrials.gov Identifier: NCT03726086
Recruitment Status : Enrolling by invitation
First Posted : October 31, 2018
Last Update Posted : March 7, 2019
Sponsor:
Collaborator:
National Institute of Nursing Research (NINR)
Information provided by (Responsible Party):
Johns Hopkins University

Study Description
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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).

Condition or disease Intervention/treatment
Intubation, Intratracheal Critical Illness Mechanical Ventilation Complication Complication of Ventilation Therapy Diagnostic Test: laryngoscopy

Study Design
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Study Type : Observational
Estimated Enrollment : 330 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Post-extubation Assessment of Laryngeal Symptoms and Severity
Actual Study Start Date : February 12, 2019
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022
Groups and Cohorts
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Intervention Details:
  • Diagnostic Test: laryngoscopy
    A flexible camera (fiberoptic endoscope) is placed in the patient's nose to view the nose, throat, and airway.

Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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 when trached, whichever comes 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. Perceptual voice characteristics as assessed by Consensus Auditory-Perceptual Evaluation of Voice (CAPE-V) [ Time Frame: Within 72 hours post-extubation ]
    Assessed from standardized voice samples and digital recordings using the CAPE-V, which is comprised of a 100-point visual analog scale ranging from 0 (normal) to 100 (severe)

  6. Perceptual voice characteristics as assessed by CAPE-V [ Time Frame: 7 days post-extubation or hospital discharge, whichever occurs first ]
    Assessed from standardized voice samples and digital recordings using the CAPE-V, which is comprised of a 100-point visual analog scale ranging from 0 (normal) to 100 (severe)

  7. 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

  8. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

Inclusion Criteria:

  • ≥18 years old
  • Required mechanical ventilation via an oral endotracheal tube
  • Anticipated intubation ≥24 hours

Exclusion Criteria:

  • Unable to understand or speak English due to a language barrier or cognitive impairment
  • Nasal endotracheal intubation during the enrolled admission
  • Pre-existing dysphonia, dysphagia
  • Pre-existing central nervous system, neuromuscular, or connective tissue disease
  • Prior tracheotomy and/or tracheotomy placed prior to enrollment
  • Prior endotracheal intubation >24 hours within 3 months
  • Head and/or neck disease
  • Head and/or neck surgery other than tonsillectomy
  • Prior major thoracic surgery (e.g., sternotomy, thoracotomy)
  • 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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03726086


Locations
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United States, Maryland
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Johns Hopkins University
National Institute of Nursing Research (NINR)
Investigators
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Principal Investigator: Martin B Brodsky, PhD, ScM Johns Hopkins University
More Information
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Publications:

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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT03726086     History of Changes
Other Study ID Numbers: IRB00151643
R01NR017433-01A1 ( U.S. NIH Grant/Contract )
First Posted: October 31, 2018    Key Record Dates
Last Update Posted: March 7, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Johns Hopkins University:
larynx
injury
voice
trachea
Additional relevant MeSH terms:
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Critical Illness
Disease Attributes
Pathologic Processes