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Can steroids help swallowing after ICU breathing tubes?

NCT ID NCT06670521

Symptom relief Sponsor: University of Colorado, Denver Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests if a short course of intravenous steroids can reduce throat swelling and improve swallowing in people recovering from a breathing tube in the ICU. About 80 adults with confirmed laryngeal edema will receive either steroids or a placebo. The goal is to see if steroids help the swelling go down faster.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 80 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2024

Expected to finish

May 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 Criteria: * 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.

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Conditions

The condition(s) this trial relates to.

Deglutition Disorders Laryngeal Edema

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Dysphagia Laryngeal edema

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • University of Colorado

    RECRUITING

    Aurora, Colorado, 80045, United States

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