Actively Recruiting

Phase 2
Age: 18Years +
All Genders
ID06670521

Randomized Trial of Corticosteroids for Post-Extubation Aspiration

Led by University of Colorado, Denver · Updated on 2026-05-06

80

Participants Needed

1

Research Sites

26 weeks

Total Duration

On this page

Sponsors

U

University of Colorado, Denver

Lead Sponsor

N

National Institute on Aging (NIA)

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating the effects of intravenous corticosteroids on laryngeal swelling and swallowing function in survivors of acute respiratory failure (ARF) who have documented laryngeal edema after being on mechanical ventilation. This randomized, placebo-controlled, double-blind trial is conducted across several major medical centers and enrolls patients from an existing longitudinal study who show laryngeal edema on fiberoptic endoscopic swallowing evaluation. The goal is to see if steroids can reduce swelling and improve swallowing quality of life after hospital discharge. Participants are randomly assigned to receive either 50 mg of methylprednisolone intravenously every six hours for four doses (total 200 mg) or a matching saline placebo on the same schedule. The study includes about 80 participants across five sites, with equal numbers in each group. The primary treatment period covers the first five days, during which swallowing function and laryngeal edema are closely monitored using the Revised Patterson Edema Scale and the Penetration-Aspiration Scale. During the study, participants undergo repeated fiberoptic endoscopic evaluations of swallowing to assess changes in laryngeal edema and swallowing safety from day 1 through day 5. Researchers will also measure quality of life related to swallowing and dietary habits one month after hospital discharge. Safety is monitored throughout, and all patients continue usual care. The total involvement includes the treatment period, follow-up assessments, and quality of life evaluations to understand the impact of corticosteroids on post-extubation dysphagia.

CONDITIONS

Brief Title

Corticosteroids for Post-Extubation Dysphagia

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Participant enrolled in primary study COMIRB #21-3873/ NCT # 05108896
  • Laryngeal edema identified on Fiberoptic Endoscopic Evaluation of Swallowing with a revised Patterson edema score greater than zero
  • Admission to an intensive care unit (ICU) during hospitalization
  • Mechanical ventilation with an endotracheal tube for more than 48 hours
  • Extubation except for compassionate extubation or transition to end-of-life care
Not Eligible

You will not qualify if you...

  • Patient or provider refusal to participate
  • Allergy to corticosteroids or current use of other immunosuppressive medications
  • Chronic treatment with corticosteroids (40 mg Prednisone/day or 32 mg Methylprednisolone/day or more)
  • Contraindication to enteral or oral nutrition
  • Pre-existing swallowing difficulties or history of aspiration
  • Pre-existing or acute primary central or peripheral neuromuscular disorders
  • Presence of chronic tracheostomy before ICU admission
  • Pre-existing head and neck cancer or surgery
  • Coagulopathy causing uncontrolled nasal or pharyngeal bleeding
  • Delirium as assessed by CAM-ICU
  • Inability to provide informed consent or have a surrogate provide consent
  • Age under 18 years

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 1 day

Participants receive either intravenous corticosteroids or a saline placebo every six hours for four doses to reduce laryngeal edema.

1 treatment day with 4 intravenous doses

Follow-up

Duration - Up to 1 month after hospitalization

Participants are monitored for changes in swallowing function and quality of life related to swallowing after hospital discharge.

Approximately 2 visits post-discharge

Trial Site Locations

Total: 1 location

1

University of Colorado

Aurora, Colorado, United States, 80045

Actively Recruiting

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Research Team

A

Anna Matheson, BSN

J

Jeffrey McKeehan, MSN

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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