Corticosteroids for Post-Extubation Dysphagia
- Conditions
- DysphagiaLaryngeal Edema
- Interventions
- Drug: Normal Saline
- Registration Number
- NCT06670521
- Lead Sponsor
- University of Colorado, Denver
- 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, 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 80
- 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.
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Corticosteroid Intervention Methylprednisolone 50 mg Methylprednisolone IV every 6 hours for 4 doses (total dose 200mg) Placebo Control Normal Saline Normal Saline placebo dose IV every 6 hours for 4 doses
- Primary Outcome Measures
Name Time Method Pre/post intervention change in the revised Patterson edema scale on FEES exam Day 1 through Day 5 Investigators hypothesize that corticosteroids will be more effective (a larger pre/post reduction in the revised Patterson Edema scale) for resolution of swallowing dysfunction in patients recovering from acute respiratory failure with the presence of laryngeal edema on a FEES examination. Change is defined as the pre-study total FEES revised Patterson Edema scale minus the post-study total FEES revised Patterson Edema scale. Improvement in the total revised Patterson Edema scale would a positive number. For example, the pre-study total score was 15, the post-study total score was 8; therefore, the change would be a score of 7. Improvement in the total revised Patterson Edema scale would a positive number
- Secondary Outcome Measures
Name Time Method Change in Individual Components of the Revised Patterson Edema Scale Day 1 through Day 5 Since there is variability in the amount of edema in the eight different locations of the revised Patterson edema scale, investigators will examine the effect of corticosteroids compared to placebo on the change in edema in each of these eight areas. Change is defined as the pre-study FEES revised Patterson Edema scale minus the post-study FEES revised Patterson Edema scale. The scale assesses eight areas of the upper airway (epiglottis, vallecula, pharyngoepiglottic folds, aryepiglottic folds, arytenoids, false vocal cords, true vocal cords, and pyriform sinuses) using a normal, mild, moderate, or severe scale. For this proposal, we have adapted this rating system to a 0-3 scale (normal =0 and severe = 3) for each of the eight locations in the upper airway. The overall score can range from 0 (normal) to 24 (severe edema in all 8 areas). The overall interrater reliability of the revised Patterson scale maintains moderate-good agreement for each of the eight upper airway locations.
Change in the Penetration-Aspiration Scale (PAS) Score Day 1 through Day 5 Investigators will determine whether the administration of corticosteroids results in improvement in the severity of dysphagia and aspiration. The PAS score is a validated measure of the degree of aspiration on FEES of the visualized swallowed bolus. A PAS score of 2-5 defined penetration of the bolus into the laryngeal area above the vocal cords but without entering the airway. A PAS score of 6 or greater defines as aspiration. A PAS score of 6-7 represents non-silent aspiration, and a score of 8 represents silent aspiration. Investigators will determine a PAS score for each bolus during the two FEES examinations.
Trial Locations
- Locations (1)
University of Colorado
🇺🇸Aurora, Colorado, United States