Post-extubation Dysphagia
Conditions
Keywords
Dysphagia, Extubation failure, repetitive transcranial magnetic stimulation
Brief summary
Post-extubation dysphagia (PED) is characterized by a range of clinical manifestations, including absence of visible swallowing effort, coughing or choking following liquid intake, and post-swallowing dysarthria. These impairments may lead to severe complications such as aspiration pneumonia, electrolyte disturbances, and malnutrition. Currently, the majority of hospitals both domestically and internationally have not implemented routine screening for PED or standardized swallowing rehabilitation programs, and research on the recovery of swallowing function in PED remains limited. This study aims to investigate the therapeutic efficacy of bilateral high-frequency repetitive transcranial magnetic stimulation (rTMS) combined with conventional swallowing training in patients with PED, and to evaluate the influence of oral feeding on functional recovery and the incidence of pneumonia. The study design is a single-center, randomized, single-blind, parallel-controlled trial. Participants with PED will be randomly assigned to either a swallowing training group or a bilateral high-frequency repetitive transcranial magnetic stimulation plus swallowing training group.The primary outcome measure is the Functional Oral Intake Scale (FOIS) score，which assesses oral feeding ability.Secondary outcomes include the Wakada Drinking Water Test(WST),degree of swallowing difficulty(GUSS),the incidence rate of pneumonia and length of stay.These secondary outcomes will provide a comprehensive evaluation of swallowing ability and hospitalization effects. Random grouping was conducted within 4 hours after extubation, and the treatment began within 2 hours and lasted for 3 consecutive days.Each rTMS session will target key brain regions.Swallowing training includes facial function training, sensory stimulation training, and airway protection techniques.The observation group received bilateral high-frequency transcranial magnetic stimulation in addition to the swallowing training.The data will be collected before and after the treatment.The primary outcome, FOIS score, will be used to assess the overall improvement in oral feeding ability.WST and GUSS data will be collected to evaluate a comprehensive evaluation of swallowing ability.The incidence rate of pneumonia and length of stay will be used to assess change in side effects. Statistical analyses will be performed using SPSS 22.0. Data will be presented as mean ± standard deviation. Between-group differences will be compared using independent samples t-tests. The study timeline spans from September 2025 to December 2026, including participant recruitment, intervention implementation, data collection, and analysis, as well as manuscript drafting. This study aims to provide new insights into the treatment methods for PED and explore a new rehabilitation approach that can be used in the ICU, with the expectation of improving swallowing disorders and reducing complications.
Interventions
BEHAVIORALSwallowing training
Swallowing training includes facial function training, sensory stimulation training, and airway protection techniques.
DEVICEa bilateral high-frequency repetitive transcranial magnetic stimulation
The interventional targets were the key cortical brain regions identified in preliminary studies, with stimulation applied to the bilateral oral and tongue regions.Parameters included a figure-of-8 coil, 10 Hz frequency, 5-second stimulation duration,55-second inter-train intervals, 10 repetitions, totaling 500 pulses per session, with each session lasting 10 minutes. Swallowing Training commenced within 10 minutes post-rTMS, following the same duration and intensity as the Swallowing Training Group . The treatment was conducted three days.
OTHERNo intervention
No intervention methods
Sponsors
Wuhan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Blinding After the intervention allocation, the participants and data analysts will be blinded. This is a single - blinded, randomized, parallel - controlled study focusing on rTMS. In the rTMS group, a 20 - minute magnetic stimulation will be applied to the target brain area.. Before the final code - breaking, data analysts won't know the group to which the data they are analyzing belongs.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age greater than 18 years; 2. Tracheal intubation for more than 48 hours; 3. Clear consciousness at the time of assessment, able to understand and follow the simple instructions of the researchers; 4. Patients have dysphagia, and the Functional Oral Intake Scale (FOIS) assessment is at levels
Exclusion criteria
1. Previous history of dysphagia; 2. Undergoing tracheotomy; 3. History of epilepsy; 4. Having metal implants in the brain; 5. Implanted with a cardiac pacemaker; 6. Under absolute isolation (such as open or infectious pulmonary tuberculosis);
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Functional Oral Intake Scale ，FOIS | Baseline (before treatment), 3 days after treatment | The oral feeding ability was conducted using the Functional Oral Intake Scale (FOIS), which is divided into 7 levels. The higher the level, the better the oral intake ability. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Wakada Drinking Water Test，WST | Baseline (before treatment), 3 days after treatment | The swallowing function was evaluated using the WST. The classification ranges from level 1 to level 5. The higher the level, the poorer the drinking ability |
| degree of swallowing difficulty，GUSS | Baseline (before treatment), 3 days after treatment | The GUSS is a widely used assessment tool for evaluating functional outcomes in dysphagia. It includes domains such as attention, spontaneous coughing, swallowing saliva, drooling, and voice.The direct swallowing test section involves screening for the swallowing of thickened food, liquid food, and solid food, respectively, to assess the situations of delayed swallowing, spontaneous coughing, drooling, and voice changes.The total score is 20 points, with 0 to 9 points indicating severe dysphagia; 10 to 14 points indicating moderate dysphagia; 15 to 19 points indicating mild dysphagia; and 20 points indicating no dysphagia. |
| length of stay | at discharge | The earlier a patient is discharged, the less financial burden it will impose on them |
Countries
China
Outcome results
None listed