Status:
RECRUITING
Corticosteroids for Post-Extubation Dysphagia
Lead Sponsor:
University of Colorado, Denver
Collaborating Sponsors:
National Institute on Aging (NIA)
Conditions:
Dysphagia
Laryngeal Edema
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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...
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 approxim...
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.
Key Trial Info
Start Date :
November 13 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 31 2027
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT06670521
Start Date
November 13 2024
End Date
May 31 2027
Last Update
November 19 2024
Active Locations (1)
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1
University of Colorado
Aurora, Colorado, United States, 80045