Screening and Intervention of Postextubation Dysphagia
- Conditions
- Oropharyngeal DysphagiaSwallowing DisorderEndotracheal IntubationRandomized Controlled Trial
- Interventions
- Behavioral: SOC program
- Registration Number
- NCT03284892
- Lead Sponsor
- National Taiwan University Hospital
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 145
- Patient who is over 20 years old.
- Patient how has received over 48 hours endotracheal intubation and had been successfully extubated.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description SOC group SOC program Received SOC program addition to usual care
- Primary Outcome Measures
Name Time Method Incidence of penetration and aspiration 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.
Resumption of oral feeding Postextubation 7 days Measured by Functional Oral Intake Scale
Incidence of pneumonia Postextubation 30 days Abstracted from electronic medical records, based on the American Thoracic Society/Infectious Diseases Society of America criteria.
- Secondary Outcome Measures
Name Time Method Oral health status score Time points of assessments: within 48 hours postextubation and at the day 10 postextubation Measured by the oral Assessment Guide
Incidence of feeding tube dependency Postextubation 30 days Abstracted from electronic medical records
Unstimulated salivary flow rate (centimeter/5 minutes) Time points of assessments: within 48 hours postextubation and at the day 10 postextubation Measured by the whatman 41 test strip
Lip closure and lingual diadochokinetic status Time points of assessments: within 48 hours postextubation and at the day 10 postextubation Measured by the Frenchay Dysarthria Assessment
Trial Locations
- Locations (1)
National Taiwan University Hospital
🇨🇳Taipei, Taiwan