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