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NCT Number: NCT06372795

Resistance Swallowing Training in Patients With Tracheotomy

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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Key information

Conditions

Swallowing Training on Muscle Strength

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

pure effortful swallowing

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.

progressive resistance swallowing training

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.

Primary outcomes

  1. Forced swallowing tongue pressure

    Time frame: Day 14 after training

    Place the pressure balloon on the prelingual pressure measurement site. The examiner placed the water in the participant 's mouth using a disposable 3 mL syringe. Subjects held 3 mL of water in their mouth and swallowed as forcefully as possible as directed by the examiner to observe instrument readings.

Sponsors and collaborators

Lead sponsor

Shanghai Zhongshan Hospital

Other

Registry information

Official study title

Effect of Early Progressive Resistance Swallowing Training on Swallowing Related Muscle Strength in Patients With Tracheotomy

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Apr 18, 2024
Registry last updated
Apr 18, 2024

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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