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Screening and Intervention of Postextubation Dysphagia

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National Taiwan University

Status

Completed

Conditions

Oropharyngeal Dysphagia
Randomized Controlled Trial
Endotracheal Intubation
Swallowing Disorder

Treatments

Behavioral: SOC program

Study type

Interventional

Funder types

Other

Identifiers

NCT03284892
201705051RIND

Details and patient eligibility

About

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.

Full 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.

Enrollment

145 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

145 participants in 2 patient groups

SOC group
Experimental group
Description:
Received SOC program addition to usual care
Treatment:
Behavioral: SOC program
Control group
No Intervention group
Description:
Received usual care only

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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