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NCT Number: NCT06791590

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

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.

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Key information

Conditions

Neurogenic Dysphagia Tracheotomy Patients

Age range

18 year–92 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beijing Rehabilitation Hospital, Capital Medical University

Beijing, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Decannulation time of the tracheostomy tube

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

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

Secondary outcomes

  1. Decannulation rate

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

    The rate of successful decannulation among enrolled patients

  2. Penetration-Aspiration Scale (PAS) score

    Time frame: up to 30 days

    The Penetration-Aspiration Scale (PAS) is a standardized tool for evaluating swallowing safety. It primarily assesses the risk of food or liquid entering the airway (aspiration) or remaining in the larynx (penetration). The scale consists of 8 levels (1-8), with higher scores indicating greater risk and severity of aspiration. It should be used in conjunction with clinical observations (FEES).

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

    Time frame: up to 30 days

    Nutritional status assessed includes albumin (ALB, g/L), prealbumin (PA, mg/L) and body mass index (BMI) at baseline,, 2 weeks after treatment and 1month after treatment.

  4. ChSwallowing Quality of Life questionnaire (ChSWAL-QoL)

    Time frame: up to 30 days

    ChSWAL-QoL was assessed using the Chinese version of the Swallowing Quality of Life scale[20] at baseline,, 2 weeks after treatment and 1month after treatment.

Sponsors and collaborators

Lead sponsor

Capital Medical University

Other

Collaborators

  • Hunan Rehabilitation Hospital
  • Zhengzhou Center Hospital

Registry information

Official study title

Evaluating the Effects of Intermittent Oro-esophageal in Tracheotomy Patients With Neurogenic Dysphagia: a Randomized Study

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jan 24, 2025
Registry last updated
Jul 6, 2026

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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