This study aims to establish a practical comprehensive intervention program for dysphagia after extubation in adult ICU patients based on the best evidence of its assessment and intervention, through expert panel discussion and Delphi method. In addition, combining the preliminary experimental results of vagus nerve stimulation applied to PED patients, we further develop a comprehensive intervention program for dysphagia after extubation based on neural regulation mechanism. Finally, the implementation effect of this PED comprehensive intervention program based on neural regulation mechanism will be verified through clinical application.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
69
Comprehensive intervention includes multidisciplinary collaboration, screening and assessment, oral sensory training, oral motor training, respiratory training, and feeding management. Transcutaneous electrical stimulation of the vagus nerve at the lateral neck was performed by rehabilitation therapists. The cervical vagus nerve accompanies the carotid artery and is located at the groove between the trachea and the sternocleidomastoid muscle, which can be located by touching the carotid pulse. The two electrodes were pasted along the path of the cervical vagus nerve.
Jinhua Municipal Central Hospital
Jinhua, China
RECRUITINGfunctional oral intake scale（FOIS）
FOIS consists of seven levels: ① Score 1, unable to eat orally at all; ② Score 2, dependent on tube feeding, minimum attempt to eat food or liquid; ③ Score 3, dependent on tube feeding, taking single texture food or liquid orally; ④ Score 4, completely oral intake of single texture food; ⑤ score 5: fully oral intake of a variety of food textures, but with special preparation or compensation; ⑥6 points, completely oral feeding without special preparation, but with special food restriction; ⑦7 points, complete oral feeding without restriction, the higher the score, the better the swallowing function of the patient. In this study, a FOIS score of 6-7 was defined as full oral feeding
Time frame: up to 90 days
standardized Swallowing Assessment（SSA）
The first part is the clinical examination.The second part involves observing the patient's ability to swallow 5 mL of water, repeated three times. If there are no abnormalities detected in the above examinations, the amount of water for swallowing is then increased to 60 mL. To obtain the total score, the scores from all three parts are summed up.
Time frame: up to 90 days
Rate of total oral feeding after the intervention
After the intervention, the patient's score on the Functional Oral Intake Scale (FOIS) was between 6 and 7, indicating that the patient has recovered the ability to eat orally.
Time frame: up to 90 days
Duration of Enteral Nutrition Tube Indwelling
The duration of the nasogastric tube or nasointestinal tube indwelling in the patient
Time frame: up to 90 days
Rate of Re-intubation after Endotracheal Intubation
The rate of re-intubation during the intervention period after extubation in patients who have undergone endotracheal intubation
Time frame: up to 90 days
Incidence of aspiration within one week after extubation
Incidence of aspiration within one week after extubation
Time frame: up to 90 days
The incidence of aspiration pneumonia within one week after extubation
The incidence of aspiration pneumonia within one week after extubation
Time frame: up to 90 days
Inflammation-related indicators: serum C-reactive protein (CRP)
Monitoring of patients' inflammatory marker
Time frame: up to 90 days
Inflammation-related indicators: serum interleukin-6 (IL-6)
Monitoring of patients' inflammatory marker
Time frame: up to 90 days
Inflammation-related indicators: serum procalcitonin, acetylcholine (ACh)
Monitoring of patients' inflammatory markers
Time frame: up to 90 days
Inflammation-related indicators: high mobility group box-1 protein (HMGB1)
Monitoring of patients' inflammatory marker
Time frame: up to 90 days
Days of ICU hospitalization
Days of ICU hospitalization
Time frame: up to 90 days
Total days of hospitalization
Total days of hospitalization
Time frame: up to 90 days
In-hospital survival rate
The number of patients who survive during hospitalization
Time frame: up to 90 days
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