StrokeNCT06299904
Effect of Modified Air-pulse Stimulation on Tracheotomised Patients With Dysphagia After Stroke
A study testing Modified Air-pulse Stimulation and Conventional air-pulse stimulation in people with Stroke, run by The Second Affiliated Hospital of Dalian Medical University at 1 site in China.
Trial summary
To evaluate the efficacy of flexible endoscopy-mediated modified air-pulse stimulation in restoring of swallowing function in this group of patients.Forty-two subacute stroke patients with tracheotomy and dysphagia need to be recruited and divided into a control group of 21 cases and a trial group of 21 cases. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Stroke
- What is being tested?
- Modified Air-pulse Stimulation and Conventional air-pulse stimulation
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2023to 1 Dec 2024
- 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 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients who met the diagnostic criteria for stroke formulated in the 4th National Academic Conference on Cerebrovascular disease;
- patients with relatively stable vital signs, with a NIHSS score of 21 points;
- patients with tracheotomy accompanied by dysphagia;
- no previous history of dysphagia;
- age ≥ 30 years and ≤80 years;
- informed consent signed by the patient and his family.
Who cannot join
- patients with medullary haemorrhage/infarction;
- patients that experienced cerebral hernia and recurrent stroke;
- patients with unstable arrhythmia, fever, infection, severe restlessness and inability to cooperate with treatment;
- patients with gastro-oesophageal reflux, bilateral paralysis of the vocal cord, laryngopharyngeal stenosis/haemorrhage/tumour;
- patients in which there was an inability to accurately locate epiglottis and arytenoid cartilage due to throat disease;
- patients with a history of epilepsy or risk of seizures.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
the Second Affiliated Hospital of Dalian Medical University
Dalian, Liaoning, 116024
wuyao Pan, postgraduate, +86-18186766836, 331189506@qq.com
About this study
To evaluate the efficacy of flexible endoscopy-mediated modified air-pulse stimulation in restoring of swallowing function in this group of patients.Forty-two subacute stroke patients with tracheotomy and dysphagia need to be recruited and divided into a control group of 21 cases and a trial group of 21 cases. On the basis of receiving personalized swallowing rehabilitation training, the control group received traditional air-pulse stimulation therapy, while the trial group received modified air-pulse stimulation therapy mediated by flexible endoscopy. Murray secretion scale (MSS), penetration-aspiration scale (PAS) and spontaneous swallowing frequency were used to assess dysphagia. Moreover, clinical pulmonary infection score (CPIS) was used for evaluating the degree of pneumonia, hemoglobin(Hb) and serum prealbumin (PAB) were used to assess the nutritional status of patients.
- Conditions
- Stroke
- Being tested
- Modified Air-pulse Stimulation, Conventional air-pulse stimulation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified Air-pulse StimulationBehavioural
Connected the oxygen humidification bottle to a fibreoptic endoscope, then inserted the terminal into the nasal cavity and the pulse sensation stimulation generated by oxygen was transmitted through the internal port of the fibreoptic endoscope to the anterior wall of the pyriform recess or to the folds of the arytenoepiglottis. (5 min once a day for 2 weeks)
Conventional air-pulse stimulationBehavioural
The terminal airway of the air pulse was placed in the oral cavity, specifically in the patient's palatoglossal arch, pharyngeal posterior wall, tongue base, and other areas. The airbag was quickly squeezed to generate airflow and stimulate the mucosa.(5 min once a day for 2 weeks)
| Study group | Role | What they receive |
|---|---|---|
| control group | Sham comparator | Based on receiving personalized swallowing rehabilitation training, the control group received traditional air-pulse stimulation therapy. Receives: Behavioral: Conventional air-pulse stimulation |
| trial group | Experimental | The trial group received modified air-pulse stimulation therapy mediated by flexible endoscopy. Receives: Behavioral: Modified Air-pulse Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
the score of Fiberoptic endoscopic examination of swallowing (FEES)
Fiberoptic endoscopic examination of swallowing
Measured: 2 weeks
the score of Murray's secretion scale (MSS)
MSS
Measured: 2 weeks
the score of penetration-aspiration scale (PAS)
PAS
Measured: 2 weeks
Secondary outcomes (1)
the score of Clinical Pulmonary Infection Score (CPIS)
CPIS
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2024
- Study start1 Dec 2023
- Primary completion1 Dec 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Second Affiliated Hospital of Dalian Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06299904
- Sponsor's protocol ID
- stroke
- Status last verified
- Mar 2024
- First submitted
- 1 Mar 2024
- Last updated
- 8 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Modified Air-pulse Stimulation on Tracheotomised Patients With Dysphagia After Stroke
- ClinicalTrials.gov ID
- NCT06299904
- Acronym / sponsor ID
- stroke
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- The Second Affiliated Hospital of Dalian Medical UniversityUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 8 Mar 2024 (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.
To evaluate the efficacy of flexible endoscopy-mediated modified air-pulse stimulation in restoring of swallowing function in this group of patients.Forty-two subacute stroke patients with tracheotomy and dysphagia need to be recruited and divided into a control group of 21 cases and a trial group of 21 cases. On the basis of receiving personalized swallowing rehabilitation training, the control group received traditional air-pulse stimulation therapy, while the trial group received modified air-pulse stimulation therapy mediated by flexible endoscopy. Murray secretion scale (MSS), penetration-aspiration scale (PAS) and spontaneous swallowing frequency were used to assess dysphagia. Moreover, clinical pulmonary infection score (CPIS) was used for evaluating the degree of pneumonia, hemoglobin(Hb) and serum prealbumin (PAB) were used to assess the nutritional status of patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | Sham comparator | Behavioral: Conventional air-pulse stimulationBased on receiving personalized swallowing rehabilitation training, the control group received traditional air-pulse stimulation therapy. |
| trial group | Experimental | Behavioral: Modified Air-pulse StimulationThe trial group received modified air-pulse stimulation therapy mediated by flexible endoscopy. |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- patients who met the diagnostic criteria for stroke formulated in the 4th National Academic Conference on Cerebrovascular disease;
- patients with relatively stable vital signs, with a NIHSS score of 21 points;
- patients with tracheotomy accompanied by dysphagia;
- no previous history of dysphagia;
- age ≥ 30 years and ≤80 years;
Key exclusion criteria (6 listed)
- patients with medullary haemorrhage/infarction;
- patients that experienced cerebral hernia and recurrent stroke;
- patients with unstable arrhythmia, fever, infection, severe restlessness and inability to cooperate with treatment;
- patients with gastro-oesophageal reflux, bilateral paralysis of the vocal cord, laryngopharyngeal stenosis/haemorrhage/tumour;
- patients in which there was an inability to accurately locate epiglottis and arytenoid cartilage due to throat disease;
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 |
|---|---|---|
| Modified Air-pulse StimulationConnected the oxygen humidification bottle to a fibreoptic endoscope, then inserted the terminal into the nasal cavity and the pulse sensation stimulation generated by oxygen was transmitted through the internal port of the fibreoptic endoscope to the anterior wall of the pyriform recess or to the folds of the arytenoepiglottis. (5 min once a day for 2 weeks) | Behavioural | trial group |
| Conventional air-pulse stimulationThe terminal airway of the air pulse was placed in the oral cavity, specifically in the patient's palatoglossal arch, pharyngeal posterior wall, tongue base, and other areas. The airbag was quickly squeezed to generate airflow and stimulate the mucosa.(5 min once a day for 2 weeks) | Behavioural | control group |
Primary outcome
the score of Fiberoptic endoscopic examination of swallowing (FEES)
Time frame: 2 weeks
Fiberoptic endoscopic examination of swallowing
the score of Murray's secretion scale (MSS)
Time frame: 2 weeks
MSS
the score of penetration-aspiration scale (PAS)
Time frame: 2 weeks
PAS
1 secondary outcome
the score of Clinical Pulmonary Infection Score (CPIS)
Time frame: 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2024.
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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 Second Affiliated Hospital of Dalian Medical University
Dalian, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Modified Air-pulse Stimulation and Conventional air-pulse stimulation in people with Stroke, run by The Second Affiliated Hospital of Dalian 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 6 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 8 Mar 2024. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the score of Fiberoptic endoscopic examination of swallowing (FEES) (time frame: 2 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Mar 2024.