Resistance Swallowing Training in Patients With Tracheotomy

NCT06372795 | Not Yet Recruiting DMC

• 1 other identifier: KY2023635
• Study Type: interventional
• Target: 66
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Swallowing Training on Muscle Strength

Outcome Measures

Primary Outcomes (1)

• Forced swallowing tongue pressure

  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.

  Day 14 after training

Study Arms (2)

Control group

ACTIVE COMPARATOR

Other: pure effortful swallowing

Test group

EXPERIMENTAL

Other: progressive resistance swallowing training

Interventions

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.

Control group

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.

Test group

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2024
• First Posted: April 18, 2024
• Study Start: May 1, 2024
• Primary Completion: May 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 18, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share