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NCT06670521 · ClinicalTrials.gov registry record · Phase 2
Corticosteroids for Post-Extubation Dysphagia
A Phase 2 study of Dysphagia and Laryngeal Edema, sponsored by University of Colorado, Denver.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 80
- Enrollment target
- 1
- Study location
NCT06670521: Recruiting Phase 2 study of Dysphagia and Laryngeal Edema, sponsored by University of Colorado, Denver.
NCT06670521 is a Phase 2 study of Dysphagia and Laryngeal Edema that is actively recruiting participants, run by University of Colorado, Denver. The registered enrollment target is 80 participants, below the 170-participant average among 35 other Dysphagia trials with a reported enrollment target (53% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06670521, a Phase 2 study of Dysphagia and Laryngeal Edema, is actively recruiting participants, sponsored by University of Colorado, Denver.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 80 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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 positi
Conditions Studied
Interventions
- DRUG Methylprednisolone
- DRUG Normal Saline
Study Locations (1)
Colorado
- University of Colorado - Aurora
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2024-11-13 |
| Est. Completion | 2027-05-31 |
| Phase | Phase 2 |
What NCT06670521 shows while recruiting
NCT06670521 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, below the 170-participant average among 35 other Dysphagia trials with a reported enrollment target (53% lower).
The record links to 2 conditions, with Dysphagia appearing as the primary indexed condition, and to 2 interventions - of which Methylprednisolone is the first listed.
NCT06670521 reports a single indexed study location in Colorado.
Frequently Asked Questions
What is clinical trial NCT06670521 about?
NCT06670521 is a clinical study titled "Corticosteroids for Post-Extubation Dysphagia". 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 ...
What is the current status of trial NCT06670521?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 80 participants. The study started on 2024-11-13. Estimated completion is 2027-05-31.
What conditions does trial NCT06670521 study?
This clinical trial studies the following conditions: Dysphagia, Laryngeal Edema.
What interventions are being tested in trial NCT06670521?
The interventions under investigation include: Methylprednisolone (DRUG), Normal Saline (DRUG).
Who is sponsoring clinical trial NCT06670521?
This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06670521 being conducted?
This trial has 1 study location across Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06670521's enrollment target sits among peer trials
80 18th of 35 higher than 18 of 35 other Dysphagia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Dysphagia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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