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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

Tracking Information
First Submitted Date October 26, 2018
First Posted Date October 31, 2018
Last Update Posted Date March 7, 2019
Actual Study Start Date February 12, 2019
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 30, 2018)
  • 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).
  • 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).
  • 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).
  • 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).
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03726086 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: October 30, 2018)
  • Oral endotracheal tube size [ Time Frame: At the time of intubation (directly following study enrollment) ]
    Size of the endotracheal tube
  • 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
  • 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).
  • 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).
  • 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)
  • 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)
  • 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
  • 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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Post-extubation Assessment of Laryngeal Symptoms and Severity
Official Title Post-extubation Assessment of Laryngeal Symptoms and Severity
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).
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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
Condition
  • Intubation, Intratracheal
  • Critical Illness
  • Mechanical Ventilation Complication
  • Complication of Ventilation Therapy
Intervention Diagnostic Test: laryngoscopy
A flexible camera (fiberoptic endoscope) is placed in the patient's nose to view the nose, throat, and airway.
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Enrolling by invitation
Estimated Enrollment
 (submitted: October 30, 2018)
330
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2022
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Eligibility 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)
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03726086
Other Study ID Numbers IRB00151643
R01NR017433-01A1 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Johns Hopkins University
Study Sponsor Johns Hopkins University
Collaborators National Institute of Nursing Research (NINR)
Investigators
Principal Investigator: Martin B Brodsky, PhD, ScM Johns Hopkins University
PRS Account Johns Hopkins University
Verification Date March 2019