National Taiwan University Hospital
Taipei, 10055, Taiwan
NCT Number: NCT03284892
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.
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Notify Me20 year and older
All sexes
Interventional
Not applicable
Taipei, 10055, Taiwan
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
A once-daily, 7-day SOC program, including oral-motor exercise, sensory stimulation and lubrication, and safe-swallowing education.
Time frame: Postextubation 7 days
Measured by Functional Oral Intake Scale
Time frame: Time points of assessments: within 48 hrs postextubation and at the day 10 postextubation
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 frame: Postextubation 30 days
Abstracted from electronic medical records, based on the American Thoracic Society/Infectious Diseases Society of America criteria.
Time frame: Postextubation 30 days
Abstracted from electronic medical records
Time frame: Time points of assessments: within 48 hours postextubation and at the day 10 postextubation
Measured by the whatman 41 test strip
Time frame: Time points of assessments: within 48 hours postextubation and at the day 10 postextubation
Measured by the oral Assessment Guide
Time frame: Time points of assessments: within 48 hours postextubation and at the day 10 postextubation
Measured by the Frenchay Dysarthria Assessment
National Taiwan University Hospital
Other
Screen and Intervene: A Diagnostic Accuracy Study and A Randomized, Open-label, Controlled Trial for Postextubation Dysphagia
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