About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Methylprednisolone
- Normal Saline
Treatment groups
Sponsors and collaborators
University of Colorado, Denver
Lead sponsor
National Institute on Aging (NIA)
Collaborator