Evaluating the Effects of Intermittent Oro-esophageal in Tracheotomy Patients With Neurogenic Dysphagia

NCT06791590 | Completed DMC

• 1 other identifier: 2025bkky-003
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

Neurogenic dysphagia refers to swallowing disorders caused by the damage of swallowing central or peripheral nerves and muscles. According to statistics, about 50% of patients with neurological diseases will be complicated with neurogenic dysphagia. Common diseases include stroke, dementia, Parkinson's disease and neuromuscular diseases. Dysphagia has a great impact on the quality of life of patients, and is related to malnutrition, aspiration pneumonia and even death. In severe cases, tracheotomy is required to maintain airway patency and discharge secretions. The common nutritional support methods for patients with neurogenic dysphagia after tracheotomy are nasogastric or nasointestinal tube placement and percutaneous gastrostomy. intermittent oro-esophageal tube feeding (IOE) is a new nutrition method proposed by scholars in recent years. Studies have shown that it can improve the swallowing function of patients with dysphagia while meeting the nutritional needs of patients, so as to effectively improve the quality of life of patients. However, there are few studies on patients with dysphagia after tracheotomy. This study aims to compare the intervention effects of two kinds of tube feeding methods in patients with neurogenic dysphagia after tracheotomy.

Conditions

Neurogenic Dysphagia; Tracheotomy Patients

Outcome Measures

Primary Outcomes (1)

• Decannulation time of the tracheostomy tube

  Decannulation time of the tracheostomy tube, corresponding to the number of days between entering the decannulation protocol to removal.

  From date of randomization until extubation, assessed up to 30 days

Secondary Outcomes (4)

• Decannulation rate

  From date of randomization until extubation, assessed up to 30 days

• Penetration-Aspiration Scale (PAS) score

  up to 30 days

• Nutritional status-albumin(ALB, g/L), prealbumin (PA, mg/L) and body mass index (BMI)

  up to 30 days

• ChSwallowing Quality of Life questionnaire (ChSWAL-QoL)

  up to 30 days

Study Arms (2)

NGT group

EXPERIMENTAL

Intranasal continuous nasogastric tube or nasogastric tube nutritional support was used. For patients at risk of repeated aspiration and regurgitation, patients with gastric nutritional intolerance who could not be improved by using gastrointestinal motility drugs, intestinal indentation tube and retropyloric feeding were given.

Procedure: Naso-intestinal tube nutrition support

IOE group

EXPERIMENTAL

Disposable gastric tube was used for enteral nutrition support

Procedure: intermittent oro-esophageal

Interventions

intermittent oro-esophageal PROCEDURE

A disposable gastric tube was used to perform enteral nutrition support therapy, and contraindications were evaluated again. Inform the patient and family members of the precautions for intermittent feeding through oral tube, and play the video of the operation process to make them actively cooperate with the operation.

IOE group

Naso-intestinal tube nutrition support PROCEDURE

For patients at risk of repeated aspiration and regurgitation, and for patients with gastric nutritional intolerance that cannot be improved by gastrointestinal motivity drugs, indwelling intestinal tube and retropyloric feeding are given.

NGT group

Eligibility Criteria

• Age: 18 Years - 92 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of neurogenic dysphagia；
• Acute phase has passed, weaning time \> 48 hours, tracheotomy time \>1 week; in accordance with the decannulation process of tracheotomy patients formulated by our center in 2018;
• steady vital signs, without severe cognitive impairment or sensory aphasia, able to cooperate with the assessment；
• Gastrointestinal motility is good, can tolerate more than 150ml/h feeding pump speed;
• Willing to sign an informed consent form.

You may not qualify if:

• Structural swallowing disorders, such as oral, pharyngeal, larynx, esophagus and other anatomical abnormalities caused by swallowing disorders;
• The clinical condition was unstable, accompanied by heart, lung, brain and other important organ dysfunction;
• Severe cognitive dysfunction, confusion, unable to cooperate.

Sponsors & Collaborators

• Hunan Rehabilitation Hospital: collaborator
• Zhengzhou Center Hospital: collaborator
• Capital Medical University: lead

Study Sites (1)

Beijing Rehabilitation Hospital, Capital Medical University

Beijing, China

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 19, 2025
• First Posted: January 24, 2025
• Study Start: January 9, 2025
• Primary Completion: October 30, 2025
• Study Completion: December 30, 2025
• Last Updated: July 6, 2026

Record last verified: 2026-07

Locations

CN (1)