Resistance Swallowing Training in Patients With Tracheotomy

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

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-01

Study Completion Date

2026-12-31

Brief Summary

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The goal of this clinical trial is to learn investigate the effect of instrument-assisted early progressive resistance swallowing training on swallowing related muscle strength in critically ill patients. It will also learn about the safety of swallowing training. The main questions it aims to answer are:

* Does instrument-assisted early progressive resistance swallowing training increase the swallowing related muscle strength in critically ill patients?
* What medical problems do participants have when taking swallowing training?

Researchers will compare instrument-assisted early progressive resistance swallowing training to pure effortful swallowing to see if instrument-assisted early progressive resistance swallowing training works to increase muscle strength.

Participants will:

-Take instrument-assisted early progressive resistance swallowing training or pure effortful swallowing every day for 2 weeks and take muscle strength test every week.

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Detailed Description

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Conditions

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Swallowing Training on Muscle Strength

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Control group

Group Type ACTIVE_COMPARATOR

pure effortful swallowing

Intervention Type OTHER

The investigator instructed the patient to "swallow forcefully while squeezing the tongue upward and backward in the direction of the soft palate" based on the sounds of an electronic timer.

Test group

Group Type EXPERIMENTAL

progressive resistance swallowing training

Intervention Type OTHER

Patients in the test group, resistance swallowing exercise was performed by providing external resistance through Iowa Oral Performance Instrument (IOPI), and all other protocols were performed the same as those in the control group.

Interventions

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pure effortful swallowing

The investigator instructed the patient to "swallow forcefully while squeezing the tongue upward and backward in the direction of the soft palate" based on the sounds of an electronic timer.

Intervention Type OTHER

progressive resistance swallowing training

Patients in the test group, resistance swallowing exercise was performed by providing external resistance through Iowa Oral Performance Instrument (IOPI), and all other protocols were performed the same as those in the control group.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Aged ≥ 18 years old
* Tracheotomy after intubation and ventilator ventilation
* Receiving treatment in ICU, and expected hospital stay \> 2 weeks after pneumonectomy
* Be able to cooperate to complete the maximum anterior tongue pressure test

Exclusion Criteria

* Inability to cooperate with tongue pressure testing and swallowing training, including disturbance of consciousness, oropharyngeal neuromuscular or motor impairment
* Patients refuse to participate in this study
* Significant malocclusion and facial asymmetry

Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No