Actively Recruiting
Corticosteroids for Post-Extubation Dysphagia
Led by University of Colorado, Denver · Updated on 2026-05-06
80
Participants Needed
1
Research Sites
130 weeks
Total Duration
On this page
Sponsors
U
University of Colorado, Denver
Lead Sponsor
N
National Institute on Aging (NIA)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Corticosteroids for Post-Extubation Dysphagia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant enrolled in primary study COMIRB #21-3873/ NCT # 05108896
- Laryngeal edema identified on primary study FEES with a revised Patterson edema score greater than zero
- Admission to an ICU during hospitalization
- Mechanical ventilation with an endotracheal tube for more than 48 hours
- Extubation except for compassionate extubation or transition to end-of-life care
You will not qualify if you...
- Patient or provider refusal
- Allergic reaction to corticosteroids or taking other immunosuppressive medications
- Chronic corticosteroid treatment (≥ 40 mg Prednisone/day or ≥32 mg Methylprednisolone/day)
- Contraindication to enteral or oral nutrition
- Pre-existing history of dysphagia or aspiration
- Pre-existing or acute primary central or peripheral neuromuscular disorder
- Presence of a chronic tracheostomy prior to ICU admission
- Pre-existing head and neck cancer or surgery
- Coagulopathy causing uncontrolled nasal or pharyngeal bleeding
- Delirium as assessed by CAM-ICU
- Inability to obtain informed consent from patient or surrogate
- Age under 18 years
AI-Screening
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Trial Site Locations
Total: 1 location
1
University of Colorado
Aurora, Colorado, United States, 80045
Actively Recruiting
Research Team
A
Anna Matheson, BSN
CONTACT
J
Jeffrey McKeehan, MSN
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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