Screening and Intervention of Postextubation Dysphagia

National Taiwan University Hospital145 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

145

Conditions

Oropharyngeal Dysphagia Swallowing Disorder Randomized Controlled Trial Endotracheal Intubation

Interventions

SOC programBEHAVIORAL

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

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

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

Locations (1)

National Taiwan University Hospital

Taipei, Taiwan

Outcomes

Primary Outcomes

Resumption of oral feeding

Measured by Functional Oral Intake Scale

Time frame: Postextubation 7 days

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 frame: Time points of assessments: within 48 hrs postextubation and at the day 10 postextubation

Incidence of pneumonia

Abstracted from electronic medical records, based on the American Thoracic Society/Infectious Diseases Society of America criteria.

Time frame: Postextubation 30 days

Secondary Outcomes

Incidence of feeding tube dependency

Abstracted from electronic medical records

Time frame: Postextubation 30 days

Unstimulated salivary flow rate (centimeter/5 minutes)

Measured by the whatman 41 test strip

Time frame: Time points of assessments: within 48 hours postextubation and at the day 10 postextubation

Oral health status score

Measured by the oral Assessment Guide

Time frame: Time points of assessments: within 48 hours postextubation and at the day 10 postextubation

Lip closure and lingual diadochokinetic status

Measured by the Frenchay Dysarthria Assessment

Time frame: Time points of assessments: within 48 hours postextubation and at the day 10 postextubation

Data from ClinicalTrials.gov

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