Screening and Intervention of Postextubation Dysphagia
Study Details
Study Description
Brief Summary
This study is to develop and test the accuracy of a two-step post-extubation dysphagia screening and the effects of PED Care intervention on reducing time to resume oral intake, rates of penetration and intervention at 10 days postextubation, and incidences of 30-day aspiration pneumonia in adult patients with prolonged intubation (≥48 hours) under a randomized controlled trial (RCT) design.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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) to develop a two-step PED Screen involved oral stereognosis and cough reflex test for detecting penetration and aspiration, using a diagnostic accuracy study method; and 2) to test effects of a once daily, 7-day PED Care intervention on reducing time to resume oral intake, rates of penetration and intervention at 10 days postextubation, and incidences of 30-day aspiration pneumonia in adult patients with prolonged intubation (≥48 hours) from a medical center in Taiwan, using a randomized controlled trial (RCT) design.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: PED Care group Received PED care addition to usual care |
Behavioral: PED care
A once daily, 7-day PED Care intervention on reducing time to resume oral intake, rates of penetration and intervention at 10 days postextubation, and incidences of 30-day aspiration pneumonia in adult patients with prolonged intubation (≥48 hours)
Diagnostic Test: FEES test
Using FEES to see if participants have any aspiration or penetration and the level of it.
Other: usual care
usual care means the original care given by the ward the participants stay.
|
| Active Comparator: Control group Received usual care only |
Diagnostic Test: FEES test
Using FEES to see if participants have any aspiration or penetration and the level of it.
Other: usual care
usual care means the original care given by the ward the participants stay.
|
Outcome Measures
Primary Outcome Measures
- Change from baseline oral intake level in one month post-extubation [Daily, until the 30th days post-extubation]
Measured by Functional Oral Intake Scale
- Change from baseline penetration and aspiration status in 10 days postextubation [First, for baseline assessment, it will be conducted within 48 hrs post-extubation after post-extubation dysphagia screening. Secondly, it will be conducted at 10-day post-extubation for every participants.]
Measured by Fiberoptic endoscopic evaluation of swallowing (FEES), a dysphagia diagnostic tool
- Change from baseline incidence of aspiration pneumonia in one month post-extubation. [Daily, following one month after extubation]
Will be assessed by Chest X-ray and interpretate by Pulmonologist
Secondary Outcome Measures
- Change from baseline Nasogastric tube insertion rate in one month post-extubation. [Daily, following one month after extubation]
To record the rate of participants who are still using nasogastric tube
- Change from baseline unstimulated salivary rate in 10th day post-extubation. [Twice, once within 48 hours post-extubation. Secondly, record it on the 10th day post-extubation.]
Assess by whatman 41 test strip.
- Change from baseline oral health status in 10th day post-extubation. [Twice, once within 48 hours post-extubation. Secondly, record it on the 10th day post-extubation.]
Assess by whatman 41 test strips.
- Change from baseline lip closure and lingual diadochokinetic ability in 10th day post-extubation. [Twice, once within 48 hours post-extubation. Secondly, record it on the 10th day post-extubation.]
Assess by Frenchay Dysarthria Assessment
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Patient who is over 20 years old.
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Patient how has received over 48 hours endotracheal intubation and had been successfully extubated.
Exclusion Criteria:
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Patient who has neurological deficits or disorders, eg. cerebrovascular disease, Parkinson disease, spinal injury.
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Patient who has innate / acquired oropharyngeal abnormality
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Patient who received tracheostomy after extubation.
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Patient who has already had swallowing dysfunction before endotracheal intubation
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Patient who cannot follow the instruction and interact with people.
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Patient who needs absolute quarantine, eg. Open Tuberculosis patients, Severe Acute Respiratory Syndrome (SARS) patients
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | National Taiwan University Hospital | Taipei | Taiwan | 10055 |
Sponsors and Collaborators
- National Taiwan University Hospital
- Ministry of Science and Technology, Taiwan
Investigators
- Principal Investigator: Cheryl Chia-Hui Chen, Prof., School of Nursing, College of Medicine, National Taiwan University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 201705051RIND