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Corticosteroids for Swallowing Difficulties After Breathing Tube Removal

This study is looking at whether a short course of intravenous (given through a vein) methylprednisolone, a type of corticosteroid, can help people who have difficulty swallowing (dysphagia) and swelling in their voice box (laryngeal edema) after having a breathing tube removed. You might be able to join if you've been in the ICU, were on a breathing machine for over 48 hours, and have swelling in your voice box identified by a special camera test (Fiberoptic Endoscopic Evaluation of Swallowing or FEES). The study compares methylprednisolone to a placebo (normal saline, which has no active medicine) to see if the medication reduces swelling and improves swallowing. Success would mean a reduction in swelling in the voice box and better swallowing function after treatment. The current recruitment status is unclear.

Study design
This is a double-blind, randomized study, meaning neither you nor your doctors will know if you are receiving the active drug or the placebo. It aims to enroll 80 participants.
What's involved
Participants will receive either methylprednisolone or normal saline intravenously every 6 hours for a total of 4 doses. Swallowing function will be assessed through Day 5, and quality of life will be checked one month after hospitalization.
Compensation
Not stated in the trial record.
Follow-up
Your swallowing function will be monitored for up to 5 days after the intervention. Quality of life related to swallowing will be assessed one month after hospitalization.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06670521

Corticosteroids for Post-Extubation Dysphagia

Recruiting
PHASE2Ages 18+InterventionalTreatment
University of Colorado, Denver
~80 participants
Updated 2026-05-06 on ClinicalTrials.gov
What's tested:MethylprednisoloneNormal Saline

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Pre/post intervention change in the revised Patterson edema scale on FEES exam
Measured over Day 1 through Day 5

Conditions

Dysphagia
Laryngeal Edema

Explore related trials

DysphagiaLaryngeal Edema

Where it's being run

1 sites across 1 states
Colorado1

Study leadership

  • Marc Moss, MD · PRINCIPAL_INVESTIGATOR · University of Colorado, Denver

Who to contact

Anna Matheson, BSN
[email protected]
4848836222
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Participant enrolled in primary study COMIRB #21-3873/ NCT # 05108896
Laryngeal edema identified on participants primary study Fiberoptic Endoscopic Evaluation of Swallowing (FEES) as defined as a revised Patterson edema score greater than zero
Admission to an ICU during their hospitalization
Mechanical ventilation with an endotracheal tube for greater than 48 hours.
Extubation except for compassionate extubation or transition to end-of-life care.

Exclusion

Patient or provider refusal
Contraindication or corticosteroids defined as an allergic reaction (extremely rate) or taking other immunosuppressive medications.
Chronic treatment with corticosteroids (\>= 40 mg Prednisone/day, \>=32 Methylprednisolone/day)
Contraindication to enteral/oral nutrition administration.
Pre-existing history of dysphagia or aspiration.
Pre-existing or acute primary central or peripheral neuromuscular disorder.
Presence of a chronic tracheostomy (present prior to ICU admission).
Pre-existing head and neck cancer or surgery.
Coagulopathy resulting in uncontrolled nasal or pharyngeal bleeding.
Delirium as assessed by CAM-ICU
Inability to obtain informed consent from patient or an appropriate surrogate.
Age \<18 years.

What this trial measures

  • Pre/post intervention change in the revised Patterson edema scale on FEES examDay 1 through Day 5

    Investigators hypothesize that corticosteroids will be more effective (a larger pre/post reduction in the revised Patterson Edema scale) for resolution of swallowing dysfunction in patients recovering from acute respiratory failure with the presence of laryngeal edema on a FEES examination. Change is defined as the pre-study total FEES revised Patterson Edema scale minus the post-study total FEES revised Patterson Edema scale. Improvement in the total revised Patterson Edema scale would a positive number. For example, the pre-study total score was 15, the post-study total score was 8; therefore, the change would be a score of 7. Improvement in the total revised Patterson Edema scale would a positive number