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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03284892
Other study ID # 201705051RIND
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 19, 2017
Est. completion date August 8, 2020

Study information

Verified date August 2020
Source National Taiwan University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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 information / eligibility

Status Completed
Enrollment 145
Est. completion date August 8, 2020
Est. primary completion date August 8, 2020
Accepts healthy volunteers No
Gender All
Age group 20 Years and older
Eligibility 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

Study Design


Intervention

Behavioral:
SOC program
A once-daily, 7-day SOC program, including oral-motor exercise, sensory stimulation and lubrication, and safe-swallowing education.

Locations

Country Name City State
Taiwan National Taiwan University Hospital Taipei

Sponsors (2)

Lead Sponsor Collaborator
National Taiwan University Hospital Ministry of Science and Technology, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Resumption of oral feeding Measured by Functional Oral Intake Scale Postextubation 7 days
Primary 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
Primary Incidence of pneumonia Abstracted from electronic medical records, based on the American Thoracic Society/Infectious Diseases Society of America criteria. Postextubation 30 days
Secondary Incidence of feeding tube dependency Abstracted from electronic medical records Postextubation 30 days
Secondary 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
Secondary Oral health status score Measured by the oral Assessment Guide Time points of assessments: within 48 hours postextubation and at the day 10 postextubation
Secondary 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
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