Using corticosteroids to improve swallowing in patients with laryngeal edema after respiratory failure
Randomized Trial of Corticosteroids for Post-Extubation Aspiration
This study is testing whether giving corticosteroids can help people who have trouble swallowing due to swelling in their throat after recovering from respiratory failure.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Colorado, Denver Academic / other |
| Drugs / interventions | Prednisone |
| Locations | 1 site (Aurora, Colorado) |
| Trial ID | NCT06670521 on ClinicalTrials.gov |
What this trial studies
This multicenter trial investigates the effects of intravenous corticosteroids on laryngeal edema and swallowing function in survivors of acute respiratory failure who have documented laryngeal edema. A total of 80 participants will be enrolled across four sites: University of Colorado, Boston University, Stanford University, and Yale University. Participants will be randomized into two groups, with one receiving corticosteroids and the other a saline placebo. The study aims to measure the reduction in laryngeal edema and evaluate improvements in swallowing function and quality of life after treatment.
Who should consider this trial
Good fit: Ideal candidates are survivors of acute respiratory failure with documented laryngeal edema who have been enrolled in a related longitudinal study.
Not a fit: Patients with pre-existing dysphagia, neuromuscular disorders, or contraindications to corticosteroids may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve swallowing function and quality of life for patients recovering from acute respiratory failure.
How similar studies have performed: While this approach is novel in this specific context, similar studies have shown promise in using corticosteroids for reducing edema in other conditions.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Aurora, Colorado
- University of Colorado — Aurora, Colorado, United States (Recruiting)
Study contacts
- Principal investigator: Marc Moss, MD — University of Colorado, Denver
- Study coordinator: Anna Matheson, BSN
- Email: anna.matheson@cuanschutz.edu
- Phone: 4848836222
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.