Neurogenic DysphagiaNCT06791590
Evaluating the Effects of Intermittent Oro-esophageal in Tracheotomy Patients With Neurogenic Dysphagia
A study testing intermittent oro-esophageal and Naso-intestinal tube nutrition support in people with Neurogenic Dysphagia and Tracheotomy Patients, run by Capital Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 92 years
- Conditions the study is for
- Neurogenic Dysphagia, Tracheotomy Patients
- What is being tested?
- intermittent oro-esophageal and Naso-intestinal tube nutrition support
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteChina
- Study dates
- 9 Jan 2025to 30 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 92 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluating the Effects of Intermittent Oro-esophageal in Tracheotomy Patients With Neurogenic Dysphagia: a Randomized Study
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
- Being tested
- intermittent oro-esophageal, Naso-intestinal tube nutrition support
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intermittent oro-esophagealProcedure or surgery
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 supportProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Naso-intestinal tube nutrition support |
| IOE group | Experimental | Disposable gastric tube was used for enteral nutrition support Receives: Procedure: intermittent oro-esophageal |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From date of randomization until extubation, assessed up to 30 days
Secondary outcomes (4)
Decannulation rate
The rate of successful decannulation among enrolled patients
Measured: From date of randomization until extubation, assessed up to 30 days
Penetration-Aspiration Scale (PAS) score
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).
Measured: up to 30 days
Nutritional status-albumin(ALB, g/L), prealbumin (PA, mg/L) and body mass index (BMI)
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.
Measured: up to 30 days
ChSwallowing Quality of Life questionnaire (ChSWAL-QoL)
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.
Measured: up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2025
- Study start9 Jan 2025
- Primary completion30 Oct 2025
- Study completion30 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neurogenic DysphagiaStudies of the same condition, open and under way.
- More trials run by Capital Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Capital Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Zhengzhou Center Hospital, Hunan Provincial Rehabilitation Hospital
- Responsible party
- Principal investigator, Jingyi Ge, Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06791590
- Sponsor's protocol ID
- 2025bkky-003
- Status last verified
- Jul 2026
- First submitted
- 19 Jan 2025
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Li Q, Hu D, Yang B, Zhang C, Zhou T, Li P, Wang Y, Zhao Z, Sun L, Jiang H. Accelerating tracheostomy decannulation with intermittent oro-esophageal feeding in neurogenic dysphagia: a multicenter randomized controlled trial. Crit Care. 2026 Aug 4;30(1):556. doi: 10.1186/s13054-026-06235-y.
PubMed 42968156
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Effects of Intermittent Oro-esophageal in Tracheotomy Patients With Neurogenic Dysphagia: a Randomized Study
- ClinicalTrials.gov ID
- NCT06791590
- Acronym / sponsor ID
- 2025bkky-003
- Conditions
- Neurogenic Dysphagia, Tracheotomy Patients
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Capital Medical UniversityUniversity, hospital or other
- Collaborators
- Zhengzhou Center Hospital, Hunan Provincial Rehabilitation Hospital
- Study start
- 9 Jan 2025 (actual)
- Primary completion
- 30 Oct 2025 (actual)
- Study completion
- 30 Dec 2025 (actual)
- First posted
- 24 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NGT group | Experimental | Procedure: Naso-intestinal tube nutrition supportIntranasal 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. |
| IOE group | Experimental | Procedure: intermittent oro-esophagealDisposable gastric tube was used for enteral nutrition support |
Who may qualify
- Ages
- 18 to 92 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| intermittent oro-esophagealA 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. | Procedure or surgery | IOE group |
| Naso-intestinal tube nutrition supportFor 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. | Procedure or surgery | NGT group |
Primary outcome
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.
4 secondary outcomes
Decannulation rate
Time frame: From date of randomization until extubation, assessed up to 30 days
Penetration-Aspiration Scale (PAS) score
Time frame: up to 30 days
Nutritional status-albumin(ALB, g/L), prealbumin (PA, mg/L) and body mass index (BMI)
Time frame: up to 30 days
ChSwallowing Quality of Life questionnaire (ChSWAL-QoL)
Time frame: up to 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
- Derived from this study: PubMed 42968156Li Q, Hu D, Yang B, Zhang C, Zhou T, Li P, Wang Y, Zhao Z, Sun L, Jiang H. Accelerating tracheostomy decannulation with intermittent oro-esophageal feeding in neurogenic dysphagia: a multicenter randomized controlled trial. Crit Care. 2026 Aug 4;30(1):556. doi: 10.1186/s13054-026-06235-y.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing intermittent oro-esophageal and Naso-intestinal tube nutrition support in people with Neurogenic Dysphagia and Tracheotomy Patients, run by Capital Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decannulation time of the tracheostomy tube (time frame: From date of randomization until extubation, assessed up to 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06791590, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2026.