CompletedNot Applicable

Post-extubation Assessment of Laryngeal Symptoms and Severity

United States365 participantsStarted 2019-02-12

Plain-language 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).

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Laryngeal injury as assessed by 4-point categorical scale

Timeframe: Within 72 hours post-extubation

Laryngeal injury symptom grading by Laryngeal Hypersensitivity Questionnaire (LHQ)

Timeframe: Within 48 hours of anticipated extubation

Laryngeal injury symptom grading by LHQ

Timeframe: Within 72 hours post-extubation

Laryngeal injury symptom grading by LHQ

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

Trial details

NCT IDNCT03726086

SponsorJohns Hopkins University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2023-06-10

View on ClinicalTrials.gov More Intubation, Intratracheal trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Laryngeal injury as assessed by 4-point categorical scale

Timeframe: Within 72 hours post-extubation

Laryngeal injury symptom grading by Laryngeal Hypersensitivity Questionnaire (LHQ)

Timeframe: Within 48 hours of anticipated extubation

Laryngeal injury symptom grading by LHQ

Timeframe: Within 72 hours post-extubation

Laryngeal injury symptom grading by LHQ

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