Recruiting
Phase 2

Corticosteroids

Sponsor:

University of Colorado, Denver

Code:

NCT06670521

Conditions

Dysphagia

Laryngeal Edema

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Methylprednisolone

Normal Saline

Study Details

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

Study ID

NCT06670521

Start date

Dec 2, 2024

Status verified date

May, 2026

Completion date

May 31, 2027

Anticipated

Primary completion date

Nov 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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

Interventions

Methylprednisolone

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

Normal Saline

Normal Saline placebo 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 and Locations

Central contacts

Anna Matheson, BSN

4848836222anna.matheson@cuanschutz.edu

Jeffrey McKeehan, MSN

3037246080jeffrey.mckeehan@cuanschutz.edu

Locations

University of Colorado

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Anna Matheson, BSN

484-883-6222anna.matheson@cuanschutz.edu

Jeffrey McKeehan, MSN

3037246080jeffrey.mckeehan@cuanschutz.edu

Principal Investigator:

Marc Moss, MD

More Information

Sponsor

University of Colorado, Denver

Last update posted

May 6, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Colorado, Denver on 2026-05-06.