Screening and Intervention of Postextubation Dysphagia

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

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.

Study Overview

• Status: Completed
• Conditions: Endotracheal Intubation; Oropharyngeal Dysphagia; Randomized Controlled Trial; Swallowing Disorder
• Intervention / Treatment: Behavioral: SOC program

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.

• Study Type: Interventional
• Enrollment (Actual): 145
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 10055
    • National Taiwan University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SOC group; Received SOC program addition to usual care	Behavioral: SOC program; A once-daily, 7-day SOC program, including oral-motor exercise, sensory stimulation and lubrication, and safe-swallowing education.
No Intervention: Control group; Received usual care only

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Resumption of oral feeding	Measured by Functional Oral Intake Scale	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 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.	Postextubation 30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of feeding tube dependency	Abstracted from electronic medical records	Postextubation 30 days
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
Oral health status score	Measured by the oral Assessment Guide	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 points of assessments: within 48 hours postextubation and at the day 10 postextubation

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Collaborators: Ministry of Science and Technology, Taiwan
• Investigators: Principal Investigator: Cheryl Chia-Hui Chen, Prof., School of Nursing, College of Medicine, National Taiwan University

Publications and helpful links

General Publications

• Siao SF, Tseng WH, Wang TG, Wei YC, Hsiao TY, Ku SC, Chen CC. Predicting feeding-tube dependence in patients following endotracheal extubation: a two-item swallowing screen. BMC Pulm Med. 2021 Dec 6;21(1):403. doi: 10.1186/s12890-021-01771-5.

Study record dates

Study Major Dates

• Study Start (Actual): September 19, 2017
• Primary Completion (Actual): August 8, 2020
• Study Completion (Actual): August 8, 2020

Study Registration Dates

• First Submitted: August 21, 2017
• First Submitted That Met QC Criteria: September 13, 2017
• First Posted (Actual): September 15, 2017

Study Record Updates

• Last Update Posted (Actual): July 20, 2023
• Last Update Submitted That Met QC Criteria: July 18, 2023
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: endotracheal intubation; randomized controlled trial; postextubation dysphagia; dysphagia intervention; dysphagia screening
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Esophageal Diseases; Deglutition Disorders
• Other Study ID Numbers: 201705051RIND

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No