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Corticosteroids for Post-Extubation Dysphagia

Randomized Trial of Corticosteroids for Post-Extubation Aspiration

Who can join

Ages 18 and older · All sexes

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.

About the study

This is a placebo-controlled, double-blind randomized trial of a short course of intravenous corticosteroids for Acute Respiratory Failure Survivors with Fiberoptic Endoscopic Evaluation of Swallowing (FEES) documented laryngeal edema. Study was leveraged using the existing R01 grant infrastructure COMIRB # 21-3873, study design, and research methods. Patients for the study proposed will have already been enrolled in the R01 longitudinal cohort study. The sites to perform this study include Colorado, BU, Yale, Tufts, and Stanford. Those R01-enrolled patients with laryngeal edema on their initial FEES examination: defined as the revised Patterson edema score greater than zero, will be approached for enrollment.

What is being tested

• Methylprednisolone (drug)
• Normal Saline (drug)

Sponsor: University of Colorado, Denver · Participants: 80 · Started: Dec 2, 2024

Contact the study team

• Anna Matheson, BSN · Phone: 4848836222
• Jeffrey McKeehan, MSN · Phone: 3037246080

Official record on ClinicalTrials.gov — NCT06670521

Locations in the U.S.

Conditions

• Swallowing Disorders

From ClinicalTrials.gov, data retrieved Oct 1, 2026. Each study sets its own eligibility; the study team decides who can join.