Screening and Intervention of Postextubation Dysphagia

Study Overview
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Brief Summary
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This clinical trial aims to test the validity of a two-item swallowing screen and to examine the effects of the Swallowing and Oral-Care (SOC) Program on resumption of oral intake, incidence of penetration and aspiration, and incidence of pneumonia in adult patients who successfully extubated after ≥ 48 hours of endotracheal intubation.

Detailed Description
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Endotracheal intubation is life-sustaining, but it may contribute to postextubation dysphagia (PED) increasing the risk of penetration, aspiration, and aspiration pneumonia. Up to 84% of extubated patients had PED and approximately 60% penetrated and aspirated that can lead to aspiration pneumonia. The aims of this three-year, two-stage study are: 1) In the first stage, the investigators develop a two-item swallowing screen involving oral stereognosis and cough reflex test for predicting the resumption of oral intake and feeding-tube dependence by using a diagnostic accuracy study method; 2) In the second stage, the investigators conduct a randomized, open-label, controlled trial design to examine the effect of a once-daily, 7-day SOC Program on resumption of oral intake, incidence of penetration and aspiration, and incidence of pneumonia in adult patients who successfully extubated after ≥ 48 hours of endotracheal intubation.

Official Title
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Screen and Intervene: A Diagnostic Accuracy Study and A Randomized, Open-label, Controlled Trial for Postextubation Dysphagia

Conditions
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Oropharyngeal Dysphagia, Swallowing Disorder, Randomized Controlled Trial, Endotracheal Intubation

Intervention / Treatment
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* Behavioral: SOC program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient who is over 20 years old. Patient how has received over 48 hours endotracheal intubation and had been successfully extubated. Exclusion Criteria: Patient who has a history of neuromuscular disease (e.g., parkinsonism or stroke) or head and neck deformities. Patient who has preexisting difficulty swallowing. Patient who has received a tracheostomy. Patient who were unable to follow verbal instructions. Patient who were on contact and droplet precautions (e.g., open tuberculosis) Patient who were receiving continuous noninvasive ventilation after extubation that precluded the delivery of an SOC intervention

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Qualified participants will receive a two-item screening and FEES examination within 48 hours postextubation. Then participants will be randomly assigned, on a 1:1 ratio, to an intervention, SOC group or a control group (receiving usual care). A research nurse will provide the SOC program for seven days or until death or hospital discharge. All outcomes, including resumption of oral feeding, incidence of pneumonia, and incidence of penetration and aspiration, will be evaluated by an independent outcome assessor.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SOC group<br>Received SOC program addition to usual care | Behavioral: SOC program<br>* A once-daily, 7-day SOC program, including oral-motor exercise, sensory stimulation and lubrication, and safe-swallowing education.<br>|
| No Intervention: Control group<br>Received usual care only | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Resumption of oral feeding | Measured by Functional Oral Intake Scale | Postextubation 7 days | 
| Incidence of penetration and aspiration | Measured by the Fiberoptic endoscopic evaluation of swallowing (FEES) with optional and the study participants either opt-in or opt-out for this procedure, given that its invasive-nature procedure. | Time points of assessments: within 48 hrs postextubation and at the day 10 postextubation | 
| Incidence of pneumonia | Abstracted from electronic medical records, based on the American Thoracic Society/Infectious Diseases Society of America criteria. | Postextubation 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of feeding tube dependency | Abstracted from electronic medical records | Postextubation 30 days | 
| Unstimulated salivary flow rate (centimeter/5 minutes) | Measured by the whatman 41 test strip | Time points of assessments: within 48 hours postextubation and at the day 10 postextubation | 
| Oral health status score | Measured by the oral Assessment Guide | Time points of assessments: within 48 hours postextubation and at the day 10 postextubation | 
| Lip closure and lingual diadochokinetic status | Measured by the Frenchay Dysarthria Assessment | Time points of assessments: within 48 hours postextubation and at the day 10 postextubation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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postextubation dysphagia, endotracheal intubation, randomized controlled trial, dysphagia intervention, dysphagia screening