Corticosteroids for Post-Extubation Dysphagia

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Dysphagia, Laryngeal Edema

In brief

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.

Key facts

Study ID

NCT06670521

Run by

University of Colorado, Denver

People needed

80

Starts

2024-12-02

Expected to finish

2027-05-31

Last updated by the study team

2026-05-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of Colorado — Aurora, Colorado, United States (enrolling)

Full record on ClinicalTrials.gov

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