NCT06670521

Corticosteroids for Post-Extubation Dysphagia

Randomized Trial of Corticosteroids for Post-Extubation Aspiration

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: University of Colorado, Denver · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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, 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.

Detailed description

This is a multicenter study conducted across the University of Colorado, Boston University, Stanford University, and Yale University. The study aims to enroll a total of 80 participants, with approximately 20 participants at each site. This study aims to investigate the effects of intravenous corticosteroids on laryngeal edema and swallowing function in survivors of acute respiratory failure (ARF) who have documented laryngeal edema. It evaluates whether administering corticosteroids can reduce edema and improve quality of life related to swallowing after hospital discharge. The study includes ARF survivors with confirmed laryngeal edema, who will be randomized into two groups. Patients in the intervention group will receive 50 mg of methylprednisolone intravenously every six hours for a total of four doses, amounting to 200 mg (equivalent to 1,000 mg of hydrocortisone), while the control group will receive a saline placebo intravenously under the same regimen. The primary outcomes of the study focus on measuring the reduction in laryngeal edema post-treatment and evaluating post-extubation swallowing function. Secondary outcomes include assessing quality of life one month after hospitalization, particularly regarding swallowing function and the ability to return to pre-hospitalization dietary habits. To measure laryngeal edema, the Revised Patterson Edema Scale will be utilized, which assesses edema across eight specific regions of the upper airway (such as the epiglottis and vallecula). Each area is rated on a scale from 0 to 3, resulting in an overall score ranging from 0 (normal) to 24 (severe edema). This scale has been adapted for the study to enhance sensitivity and reliability, showing moderate to good interrater reliability across assessed areas. Participants will be randomized in a 1:1 ratio using a permuted block randomization method to ensure balanced allocation. The findings from this study could have significant implications for post-extubation care in ARF survivors, potentially guiding clinical practices for managing laryngeal edema and improving patients' swallowing function and overall quality of life after hospitalization.

Conditions

• Dysphagia
• Laryngeal Edema

Interventions

Type	Name	Description
DRUG	Methylprednisolone	50 mg methylprednisolone IV every 6 hours for 4 doses to reduce laryngeal edema
DRUG	Normal Saline	Normal Saline placebo IV every 6 hours for 4 doses

Timeline

• Start date: 2024-11-13
• Primary completion: 2026-11-30
• Completion: 2027-05-31
• First posted: 2024-11-01
• Last updated: 2024-11-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study