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RECRUITING
NCT06670521
PHASE2

Corticosteroids for Post-Extubation Dysphagia

Sponsor: University of Colorado, Denver

View on ClinicalTrials.gov

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, 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.

Official title: Randomized Trial of Corticosteroids for Post-Extubation Aspiration

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

80

Start Date

2024-11-13

Completion Date

2027-05-31

Last Updated

2024-11-19

Healthy Volunteers

No

Interventions

DRUG

Methylprednisolone

50 mg methylprednisolone IV every 6 hours for 4 doses to reduce laryngeal edema

DRUG

Normal Saline

Normal Saline placebo IV every 6 hours for 4 doses

Locations (1)

University of Colorado

Aurora, Colorado, United States