Screening and Intervention of Postextubation Dysphagia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

145 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-19

Study Completion Date

2020-08-08

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effects of an Swallowing and Oral Care Program in Patients Following Prolonged Endotracheal Intubation

NCT02334774

Dysphagia Endotracheal Intubation Intake Status +1 more

COMPLETED NA

No Post Intubation Laryngeal Symptoms

NCT05383417

Sore-throat Dysphonia Dysphagia +9 more

COMPLETED NA

Post-extubation Assessment of Laryngeal Symptoms and Severity

NCT03726086

Intubation, Intratracheal Critical Illness Mechanical Ventilation Complication +1 more

COMPLETED

The Use of PEDI_ EAT 10 Score Versus Nurse Performed Screening in the Assessment of Post Extubation Dysphagia

NCT05828537

Pediatric Post Extubation Dysphagia

UNKNOWN

Valuation of Swallowing in Patient Sedated for Gastroenteric Endoscopic Procedure

NCT01789424

Sedation for Gastroenteric Endoscopic Procedure Deglutition Disorders Aspiration of Food

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Oropharyngeal Dysphagia Swallowing Disorder Randomized Controlled Trial Endotracheal Intubation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Qualified participants will receive a two-item screening and FEES examination within 48 hours postextubation. Then participants will be randomly assigned, on a 1:1 ratio, to an intervention, SOC group or a control group (receiving usual care). A research nurse will provide the SOC program for seven days or until death or hospital discharge. All outcomes, including resumption of oral feeding, incidence of pneumonia, and incidence of penetration and aspiration, will be evaluated by an independent outcome assessor.

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

To maintain allocation concealment, the investigators ensured that only the intervention nurse had access to the random sequence. Physicians and staff at the study sites were aware of a pending nursing-intervention study but were blinded with respect to the hypothesis, group allocation, specific SOC protocols, and study endpoints. Moreover, outcome assessors were blinded to the group assignments, ensuring an unbiased evaluation.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

SOC group

Received SOC program addition to usual care

Group Type EXPERIMENTAL

SOC program

Intervention Type BEHAVIORAL

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

Control group

Received usual care only

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

SOC program

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

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No