Corticosteroids for Post-Extubation Dysphagia

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Colorado, Denver

About this trial

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, Tufts, 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Methylprednisolone

    Drug

    50 mg methylprednisolone IV every 6 hours for 4 doses to reduce laryngeal edema

  • Normal Saline

    Drug

    Normal Saline placebo IV every 6 hours for 4 doses

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Corticosteroid InterventionExperimental treatment 1 intervention
Group B: Placebo ControlPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Pre/post intervention change in the revised Patterson edema scale on FEES exam

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 positive number. For example, the pre-study total score was 15, the post-study total score was 8; therefore, the change would be a score of 7. Improvement in the total revised Patterson Edema scale would a positive number

Time frame
Day 1 through Day 5

Secondary outcomes

1

Change in Individual Components of the Revised Patterson Edema Scale

Since there is variability in the amount of edema in the eight different locations of the revised Patterson edema scale, investigators will examine the effect of corticosteroids compared to placebo on the change in edema in each of these eight areas. Change is defined as the pre-study FEES revised Patterson Edema scale minus the post-study FEES revised Patterson Edema scale. The scale assesses eight areas of the upper airway (epiglottis, vallecula, pharyngoepiglottic folds, aryepiglottic folds, arytenoids, false vocal cords, true vocal cords, and pyriform sinuses) using a normal, mild, moderate, or severe scale. For this proposal, we have adapted this rating system to a 0-3 scale (normal =0 and severe = 3) for each of the eight locations in the upper airway. The overall score can range from 0 (normal) to 24 (severe edema in all 8 areas). The overall interrater reliability of the revised Patterson scale maintains moderate-good agreement for each of the eight upper airway locations.

Time frame
Day 1 through Day 5
2

Change in the Penetration-Aspiration Scale (PAS) Score

Investigators will determine whether the administration of corticosteroids results in improvement in the severity of dysphagia and aspiration. The PAS score is a validated measure of the degree of aspiration on FEES of the visualized swallowed bolus. A PAS score of 2-5 defined penetration of the bolus into the laryngeal area above the vocal cords but without entering the airway. A PAS score of 6 or greater defines as aspiration. A PAS score of 6-7 represents non-silent aspiration, and a score of 8 represents silent aspiration. Investigators will determine a PAS score for each bolus during the two FEES examinations.

Time frame
Day 1 through Day 5

Other outcomes

1

Return to Pre-Hospitalization Diet

Participants will be contacted by telephone one month after hospital discharge to assess their return to Pre-Hospitalization Diet. A pre-hospitalization diet has already been established in the primary study, 21-3873. Study personnel will ask participants about their current diet post-discharge. Returning to the pre-hospitalization diet will be defined as resuming the same diet they followed before hospitalization.

Time frame
1 month post-hospital discharge
2

Post-Discharge Eating Assessment Tool (EAT-10)

Participants will be contacted by telephone one month after hospital discharge to complete dysphagia screening tool to identify people at high risk of swallowing disorders. Each item corresponds to 5 difficulty levels from "no problem" to "serious problem," with a total score of 0 to 40. EAT-10 has good internal consistency and intraclass correlation coefficients (ICCs).

Time frame
1 month post-hospital discharge
3

Post-Discharge Positive and Negative Affect Schedule (PANAS-SF)

Participants will be contacted by telephone one month after hospital discharge to complete 20-item questionnaire to assess positive affect (PA) and negative affect (NA). PA is associated with pleasurable engagement with the environment, whereas NA reflects a dimension of general distress summarizing a variety of negative states such as anger, guilt, or anxiety. Positive Affect Score: Add the scores on items 1, 3, 5, 9, 10, 12, 14, 16, 17, and 19. Scores can range from 10 - 50, with higher scores representing higher levels of positive affect. Mean Scores: 33.3 (SD±7.2) Negative Affect Score: Add the scores on items 2, 4, 6, 7, 8, 11, 13, 15, 18, and 20. Scores can range from 10 - 50, with lower scores representing lower levels of negative affect. Mean Score: 17.4 (SD ± 6.2)

Time frame
1 month post-hospital discharge
4

Post-Discharge Caregiver Assistance Scale (CAS)

Participants will be contacted by telephone one month after hospital discharge to complete an assessment tool to collect data on how much assistance the caregiver provides to the participant for various activities over the past month. A rating of zero (0) indicates "no" assistance is provided, while a rating of six (6) indicates "a lot" is provided.

Time frame
1 month post-hospital discharge

Sponsors and contacts

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University of Colorado, Denver

Lead sponsor

National Institute on Aging (NIA)

Collaborator