Screening and Intervention of Postextubation Dysphagia

Endotracheal Intubation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03284892
• Other study ID #: 201705051RIND
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Deglutition Disorders
• Endotracheal Intubation
• Oropharyngeal Dysphagia
• Randomized Controlled Trial
• Swallowing Disorder

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