Corticosteroids for Post-Extubation Dysphagia

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Colorado, Denver

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

80 Participants
are divided into 2 treatment groups

Sponsors and collaborators

University of Colorado, Denver

Lead sponsor

National Institute on Aging (NIA)

Collaborator