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

July 3, 2023 updated by: Johns Hopkins University
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

365

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

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

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Within 72 hours post-extubation
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).
Within 48 hours of anticipated extubation
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).
Within 72 hours post-extubation
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).
7 days post-extubation or hospital discharge, whichever occurs first

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oral endotracheal tube size
Time Frame: At the time of intubation (directly following study enrollment)
Size of the endotracheal tube
At the time of intubation (directly following study enrollment)
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
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
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).
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
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
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
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
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)
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).
Within 72 hours post-extubation and at 7 days post-extubation or hospital discharge, whichever occurs first
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
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)
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)
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
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.
Within 72 hours post-extubation
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.
Within 90 days of extubation or at ICU discharge, whichever occurs first

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins University

Collaborators

National Institute of Nursing Research (NINR)

Investigators

  • Principal Investigator: Dale M. Needham, MD, PhD, Johns Hopkins University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 12, 2019

Primary Completion (Actual)

June 10, 2023

Study Completion (Actual)

June 10, 2023

Study Registration Dates

First Submitted

October 26, 2018

First Submitted That Met QC Criteria

October 30, 2018

First Posted (Actual)

October 31, 2018

Study Record Updates

Last Update Posted (Actual)

July 6, 2023

Last Update Submitted That Met QC Criteria

July 3, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00151643
  • R01NR017433-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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