Clinical trial NCT06670521: Corticosteroids for Post-Extubation Dysphagia
Official title: Randomized Trial of Corticosteroids for Post-Extubation Aspiration
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Dysphagia
Laryngeal Edema
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2024-11-01
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Multicenter prospective randomized clinical trial
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Pre/post intervention change in the revised Patterson edema scale on FEES exam
timeFrame: Day 1 through Day 5
Secondary outcomes:
measure: Change in Individual Components of the Revised Patterson Edema Scale
timeFrame: Day 1 through Day 5
measure: Change in the Penetration-Aspiration Scale (PAS) Score
timeFrame: Day 1 through Day 5
Other outcomes:
measure: Return to Pre-Hospitalization Diet
timeFrame: 1 month post-hospital discharge
measure: Post-Discharge Eating Assessment Tool (EAT-10)
timeFrame: 1 month post-hospital discharge
measure: Post-Discharge Positive and Negative Affect Schedule (PANAS-SF)
timeFrame: 1 month post-hospital discharge
measure: Post-Discharge Caregiver Assistance Scale (CAS)
timeFrame: 1 month post-hospital discharge
measure: Post-Discharge Caregiving Impact Scale (CIS)
timeFrame: 1 month post-hospital discharge
measure: Post-Discharge 20-Item Medical Outcomes Study (MOS) Social Support Survey
timeFrame: 1 month post-hospital discharge
Locations:
city: Aurora
country: United States
facility: University of Colorado
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Marc Moss, MD
role: PRINCIPAL_INVESTIGATOR
References: