RECRUITING

Corticosteroids for Post-Extubation Dysphagia

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

Randomized Trial of Corticosteroids for Post-Extubation Aspiration

Quick Facts

Study Start:2024-11-13
Study Completion:2027-05-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06670521

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Participant enrolled in primary study COMIRB #21-3873/ NCT # 05108896
  2. * Laryngeal edema identified on participants primary study Fiberoptic Endoscopic Evaluation of Swallowing (FEES) as defined as a revised Patterson edema score greater than zero
  3. * Admission to an ICU during their hospitalization
  4. * Mechanical ventilation with an endotracheal tube for greater than 48 hours.
  5. * Extubation except for compassionate extubation or transition to end-of-life care.
  1. * Patient or provider refusal
  2. * Contraindication or corticosteroids defined as an allergic reaction (extremely rate) or taking other immunosuppressive medications.
  3. * Chronic treatment with corticosteroids (\>= 40 mg Prednisone/day, \>=32 Methylprednisolone/day)
  4. * Contraindication to enteral/oral nutrition administration.
  5. * Pre-existing history of dysphagia or aspiration.
  6. * Pre-existing or acute primary central or peripheral neuromuscular disorder.
  7. * Presence of a chronic tracheostomy (present prior to ICU admission).
  8. * Pre-existing head and neck cancer or surgery.
  9. * Coagulopathy resulting in uncontrolled nasal or pharyngeal bleeding.
  10. * Delirium as assessed by CAM-ICU
  11. * Inability to obtain informed consent from patient or an appropriate surrogate.
  12. * Age \<18 years.

Contacts and Locations

Study Contact

Anna Matheson, BSN
CONTACT
4848836222
anna.matheson@cuanschutz.edu
Jeffrey McKeehan, MSN
CONTACT
3037246080
jeffrey.mckeehan@cuanschutz.edu

Principal Investigator

Marc Moss, MD
PRINCIPAL_INVESTIGATOR
University of Colorado, Denver

Study Locations (Sites)

University of Colorado
Aurora, Colorado, 80045
United States

Collaborators and Investigators

Sponsor: University of Colorado, Denver

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-11-13
Study Completion Date2027-05-31

Study Record Updates

Study Start Date2024-11-13
Study Completion Date2027-05-31

Terms related to this study

Additional Relevant MeSH Terms

  • Dysphagia
  • Laryngeal Edema