University of Colorado, Denver
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.
This is a multicenter study conducted across the University of Colorado, Boston University, Stanford University, Tufts Medical Center, and Yale University. The study aims to enroll a total of 80 participants, with approximately 20 participants at each site. This study aims to investigate the effects of intravenous corticosteroids on laryngeal edema and swallowing function in survivors of acute respiratory failure (ARF) who have documented laryngeal edema. It evaluates whether administering corticosteroids can reduce edema and improve quality of life related to swallowing after hospital dischar…
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 reac…
50 mg methylprednisolone IV every 6 hours for 4 doses to reduce laryngeal edema
Normal Saline placebo IV every 6 hours for 4 doses
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