- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06299904
Effect of Modified Air-pulse Stimulation on Tracheotomised Patients With Dysphagia After Stroke
March 1, 2024 updated by: The Second Affiliated Hospital of Dalian Medical University
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 Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
42
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Liaoning
-
Dalian, Liaoning, China, 116024
- Recruiting
- The Second Affiliated Hospital of Dalian Medical University
-
Contact:
- wuyao Pan, postgraduate
- Phone Number: +86-18186766836
- Email: 331189506@qq.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Sham Comparator: control group
Based on receiving personalized swallowing rehabilitation training, the control group received traditional air-pulse stimulation therapy.
|
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)
|
Experimental: trial group
The trial group received modified air-pulse stimulation therapy mediated by flexible endoscopy.
|
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)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
the score of Fiberoptic endoscopic examination of swallowing (FEES)
Time Frame: 2 weeks
|
Fiberoptic endoscopic examination of swallowing
|
2 weeks
|
the score of Murray's secretion scale (MSS)
Time Frame: 2 weeks
|
MSS
|
2 weeks
|
the score of penetration-aspiration scale (PAS)
Time Frame: 2 weeks
|
PAS
|
2 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
the score of Clinical Pulmonary Infection Score (CPIS)
Time Frame: 2 weeks
|
CPIS
|
2 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 1, 2023
Primary Completion (Estimated)
December 1, 2024
Study Completion (Estimated)
December 1, 2024
Study Registration Dates
First Submitted
March 1, 2024
First Submitted That Met QC Criteria
March 1, 2024
First Posted (Actual)
March 8, 2024
Study Record Updates
Last Update Posted (Actual)
March 8, 2024
Last Update Submitted That Met QC Criteria
March 1, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- stroke
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Stroke
-
University Hospital, GhentRecruitingStroke | Stroke, Ischemic | Stroke, Acute | Stroke Sequelae | Stroke HemorrhagicBelgium
-
Moleac Pte Ltd.RecruitingStroke | Stroke, Ischemic | Stroke Sequelae | Stroke, Cardiovascular | Strokes Thrombotic | Stroke, Embolic | Stroke, CryptogenicSingapore, Philippines
-
Moleac Pte Ltd.Not yet recruitingStroke | Stroke, Ischemic | Stroke Sequelae | Stroke, Cardiovascular | Strokes Thrombotic | Stroke, Embolic | Stroke, Cryptogenic
-
IRCCS San Camillo, Venezia, ItalyRecruitingStroke | Stroke, Ischemic | Stroke Sequelae | Stroke HemorrhagicItaly
-
Vanderbilt University Medical CenterPatient-Centered Outcomes Research Institute; University of Alabama at BirminghamEnrolling by invitationStroke | Stroke, Ischemic | Stroke, Acute | Stroke Sequelae | Engagement, Patient | Stroke HemorrhagicUnited States
-
University of MinnesotaAmerican Occupational Therapy FoundationRecruitingStroke | Stroke Sequelae | Stroke Hemorrhagic | Stroke IschemicUnited States
-
University of British ColumbiaCanadian Institutes of Health Research (CIHR); Michael Smith Foundation for...RecruitingStroke | Stroke, Ischemic | Stroke Hemorrhagic | Chronic StrokeCanada
-
University of CincinnatiMedical University of South Carolina; University of California, Los Angeles; University...RecruitingStroke | Stroke, Ischemic | Stroke, Acute | Stroke HemorrhagicUnited States
-
Turkish Stroke Research and Clinical Trials NetworkElectroCore INC; Turkish Neurological SocietyCompletedStroke | Stroke, Ischemic | Stroke, Acute | Stroke, HemorrhagicTurkey
-
University of LiegeCompletedStroke, Acute | Stroke Hemorrhagic | Stroke, ComplicationBelgium
Clinical Trials on Conventional air-pulse stimulation
-
Medical University of ViennaCampus Bio-Medico UniversityRecruitingFatigue | Post-COVID-19 SyndromeAustria, Italy
-
NuvectraBright Research PartnersTerminated
-
Changping LaboratoryRecruiting
-
University of FloridaNational Institute of Neurological Disorders and Stroke (NINDS); MedtronicRecruitingParkinson Disease | Dystonia | Essential TremorUnited States
-
University of FloridaRecruiting
-
Western University, CanadaRecruiting
-
Nu Eyne Co., Ltd.CompletedDry Eye DiseaseKorea, Republic of
-
The Hong Kong Polytechnic UniversityRecruitingAutism Spectrum Disorder | High-functioning AutismHong Kong
-
The Hong Kong Polytechnic UniversityRecruitingMajor Depressive DisorderHong Kong
-
Nu Eyne Co., Ltd.CompletedGlaucomaKorea, Republic of