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Completed

NCT Number: NCT03284892

Screening and Intervention of 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.

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Key information

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Taiwan University Hospital

Taipei, 10055, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SOC program

Behavioral

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

Primary outcomes

  1. Resumption of oral feeding

    Time frame: Postextubation 7 days

    Measured by Functional Oral Intake Scale

  2. Incidence of penetration and aspiration

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

    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.

  3. Incidence of pneumonia

    Time frame: Postextubation 30 days

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

Secondary outcomes

  1. Incidence of feeding tube dependency

    Time frame: Postextubation 30 days

    Abstracted from electronic medical records

  2. Unstimulated salivary flow rate (centimeter/5 minutes)

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

    Measured by the whatman 41 test strip

  3. Oral health status score

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

    Measured by the oral Assessment Guide

  4. Lip closure and lingual diadochokinetic status

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

    Measured by the Frenchay Dysarthria Assessment

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Collaborators

  • Ministry of Science and Technology, Taiwan

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Sep 15, 2017
Registry last updated
Jul 20, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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