Corticosteroids for Post-Extubation Dysphagia

Part of paid clinical trials in Aurora, Colorado.

Sponsor
University of Colorado, Denver
Study ID
NCT06670521
Phase
PHASE2
Status
Recruiting
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Conditions

  • Dysphagia
  • Laryngeal Edema

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Methylprednisolone — DRUG
    50 mg methylprednisolone IV every 6 hours for 4 doses to reduce laryngeal edema
  • Normal Saline — DRUG
    Normal Saline placebo IV every 6 hours for 4 doses

Study Details

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.

Key Dates

Start date
Dec 2, 2024
Status verified
May 2026
Primary completion
Nov 30, 2026
Completion
May 31, 2027

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Corticosteroid Intervention
    50 mg Methylprednisolone IV every 6 hours for 4 doses (total dose 200mg)
  • Placebo Comparator: Placebo Control
    Normal Saline placebo dose IV every 6 hours for 4 doses

Primary Outcome Measure

Pre/post intervention change in the revised Patterson edema scale on FEES exam [ Time Frame: Day 1 through Day 5 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of ColoradoAuroraColorado80045
Anna Matheson, BSN
[email protected]
484-883-6222
Jeffrey McKeehan, MSN
[email protected]
3037246080
Marc Moss, MD (PRINCIPAL_INVESTIGATOR)

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