Using corticosteroids to improve swallowing in patients with laryngeal edema after respiratory failure

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.