Corticosteroids for Post-Extubation Dysphagia

Description

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.

Conditions

Dysphagia, Laryngeal Edema

Talk to us

Study Overview

On this page

Study Details

Study overview

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.

Randomized Trial of Corticosteroids for Post-Extubation Aspiration

Corticosteroids for Post-Extubation Dysphagia

Condition
Dysphagia
Intervention / Treatment

-

Contacts and Locations

Aurora

University of Colorado, Aurora, Colorado, United States, 80045

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Colorado, Denver,

Marc Moss, MD, PRINCIPAL_INVESTIGATOR, University of Colorado, Denver

Study Record Dates

2027-05-31