drugset / Trial / NCT06670521
Corticosteroids for Post-Extubation Dysphagia
Phase 2
Recruiting
80 enrolled
University of Colorado, Denver
National Institute on Aging (NIA) · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
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.
Timeline
- Start
- 2024-12-02
- Primary completion
- 2026-11-30
- Completion
- 2027-05-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Methylprednisolone | Other / unclassified | 50 mg | Intravenous |
Indications
No indication recorded.