Corticosteroids for Post-Extubation Dysphagia

Launched by UNIVERSITY OF COLORADO, DENVER · Oct 30, 2024

Keywords

ClinConnect Summary

This clinical trial is exploring the use of a short course of intravenous corticosteroids to help patients who have difficulty swallowing (dysphagia) due to swelling in the throat (laryngeal edema) after being on a breathing machine (mechanical ventilation). The study will involve patients who have already been part of another research project and have shown signs of throat swelling during a specific swallowing test. It aims to determine if corticosteroids can improve swallowing and overall recovery.

To participate, individuals must be between the ages of 65 and 74, have been admitted to an intensive care unit (ICU), and have experienced difficulty swallowing after being extubated (taken off the breathing tube). However, some people may not be eligible if they have certain medical conditions, are currently taking strong medications that suppress the immune system, or have a history of severe swallowing problems. Participants will receive either the corticosteroid treatment or a placebo (a treatment that looks the same but has no active medication) and will be monitored for their swallowing ability and recovery progress.

Gender

ALL

Eligibility 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.