Corticosteroids for Post-Extubation Dysphagia (NCT06670521) | Clinical Trial Compass
RecruitingPhase 2
Corticosteroids for Post-Extubation Dysphagia
United States80 participantsStarted 2024-12-02
Plain-language 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, Tufts, 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Pre/post intervention change in the revised Patterson edema scale on FEES exam