Resistance Swallowing Training in Patients With Tracheotomy

Not Applicable

Not yet recruiting

• Conditions: Swallowing Training on Muscle Strength
• Interventions: Other: progressive resistance swallowing training; Other: pure effortful swallowing

• Registration Number: NCT06372795
• Lead Sponsor: Shanghai Zhongshan Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-04
• Study First Submitted: 2024-04-15
• Study First Submitted QC: 2024-04-15
• Last Update Submitted: 2024-04-15
• Study First Posted: 2024-04-18
• Last Update Posted: 2024-04-18
• Study Start: 2024-05-01
• Primary Completion: 2026-05-01
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 66

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Test group	progressive resistance swallowing training	-
Control group	pure effortful swallowing	-

Primary Outcome Measures

Name	Time	Method
Forced swallowing tongue pressure	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.