NCT06670521 Corticosteroids for Post-Extubation Dysphagia
| NCT ID | NCT06670521 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University of Colorado, Denver |
| Condition | Dysphagia |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2024-12-02 |
| Primary Completion | 2026-11-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 80 participants in total. It began in 2024-12-02 with a primary completion date of 2026-11-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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, 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.
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.
Contact & Investigator
Marc Moss, MD
PRINCIPAL INVESTIGATOR
University of Colorado, Denver
Frequently Asked Questions
Who can join the NCT06670521 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Dysphagia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06670521 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06670521 currently recruiting?
Yes, NCT06670521 is actively recruiting participants. Contact the research team at anna.matheson@cuanschutz.edu for enrollment information.
Where is the NCT06670521 trial being conducted?
This trial is being conducted at Aurora, United States.
Who is sponsoring the NCT06670521 clinical trial?
NCT06670521 is sponsored by University of Colorado, Denver. The principal investigator is Marc Moss, MD at University of Colorado, Denver. The trial plans to enroll 80 participants.