Corticosteroids for Post-Extubation Dysphagia

NCT06670521 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: 24-1535R21AG089278
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Dysphagia; Laryngeal Edema

Outcome Measures

Primary Outcomes (1)

• Pre/post intervention change in the revised Patterson edema scale on FEES exam

  Investigators hypothesize that corticosteroids will be more effective (a larger pre/post reduction in the revised Patterson Edema scale) for resolution of swallowing dysfunction in patients recovering from acute respiratory failure with the presence of laryngeal edema on a FEES examination. Change is defined as the pre-study total FEES revised Patterson Edema scale minus the post-study total FEES revised Patterson Edema scale. Improvement in the total revised Patterson Edema scale would a positive number. For example, the pre-study total score was 15, the post-study total score was 8; therefore, the change would be a score of 7. Improvement in the total revised Patterson Edema scale would a positive number

  Day 1 through Day 5

Secondary Outcomes (2)

• Change in Individual Components of the Revised Patterson Edema Scale

  Day 1 through Day 5

• Change in the Penetration-Aspiration Scale (PAS) Score

  Day 1 through Day 5

Other Outcomes (6)

• Return to Pre-Hospitalization Diet

  1 month post-hospital discharge

• Post-Discharge Eating Assessment Tool (EAT-10)

  1 month post-hospital discharge

• Post-Discharge Positive and Negative Affect Schedule (PANAS-SF)

  1 month post-hospital discharge

Study Arms (2)

Corticosteroid Intervention

EXPERIMENTAL

50 mg Methylprednisolone IV every 6 hours for 4 doses (total dose 200mg)

Drug: Methylprednisolone

Placebo Control

PLACEBO COMPARATOR

Normal Saline placebo dose IV every 6 hours for 4 doses

Drug: Normal Saline

Interventions

Methylprednisolone DRUG

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

Corticosteroid Intervention

Normal Saline DRUG

Normal Saline placebo IV every 6 hours for 4 doses

Placebo Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Pre-existing history of dysphagia or aspiration.
• Pre-existing or acute primary central or peripheral neuromuscular disorder.
• Presence of a chronic tracheostomy (present prior to ICU admission).
• Pre-existing head and neck cancer or surgery.
• Coagulopathy resulting in uncontrolled nasal or pharyngeal bleeding.
• Delirium as assessed by CAM-ICU
• Inability to obtain informed consent from patient or an appropriate surrogate.
• Age \<18 years.

Sponsors & Collaborators

• University of Colorado, Denver: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

University of Colorado

Aurora, Colorado, 80045, United States

RECRUITING

MeSH Terms

Conditions

Deglutition Disorders; Laryngeal Edema

Interventions

Methylprednisolone; Saline Solution

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Laryngeal Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Marc Moss, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anna Matheson, BSN

CONTACT

4848836222; anna.matheson@cuanschutz.edu

Jeffrey McKeehan, MSN

CONTACT

3037246080; jeffrey.mckeehan@cuanschutz.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double blinded placebo controlled
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Multicenter prospective randomized clinical trial

Study Record Dates

• First Submitted: September 19, 2024
• First Posted: November 1, 2024
• Study Start: December 2, 2024
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): May 31, 2027
• Last Updated: May 6, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)