Post-extubation Dysphagia
Conditions
Keywords
post-extubation dysphagia, electrical stimulation
Brief summary
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.
Interventions
OTHERComprehensive Intervention or Comprehensive Intervention Combined with Electrical vagus nerve stimulation
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.
Sponsors
Jinhua Municipal Central Hospital
Second Affiliated Hospital, School of Medicine, Zhejiang University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
1. Patients who met the diagnostic criteria of PED were changed to SSA score ≥24 2. aged from 18 to 90 years old; 3. oral or nasotracheal intubation for ≥48 hours; 4. Clear mind 5. Glasgow score ≥13 points, with good cooperation ability; 6. There was no contraindication to oral feeding after extubation
Exclusion criteria
1. Other diseases that affect swallowing function (such as stroke, Parkinson's disease, head and neck deformity, radiotherapy after head and neck cancer, burn with inhalation injury, esophageal cancer, chronic obstructive pulmonary disease, etc.); 2. history of reflux and aspiration; 3. tracheotomy; 4. isolation treatment due to respiratory infectious diseases; 5. the presence of implantable electronic devices (e.g., pacemakers, cochlear implants); 6. Traumatic vagus recurrent laryngeal nerve injury, history of vagus nerve surgery, or vagus nerve injury
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| functional oral intake scale（FOIS） | up to 90 days | 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 |
| standardized Swallowing Assessment（SSA） | up to 90 days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Re-intubation after Endotracheal Intubation | up to 90 days | The rate of re-intubation during the intervention period after extubation in patients who have undergone endotracheal intubation |
| Incidence of aspiration within one week after extubation | up to 90 days | Incidence of aspiration within one week after extubation |
| The incidence of aspiration pneumonia within one week after extubation | up to 90 days | The incidence of aspiration pneumonia within one week after extubation |
| Inflammation-related indicators: serum C-reactive protein (CRP) | up to 90 days | Monitoring of patients' inflammatory marker |
| Inflammation-related indicators: serum interleukin-6 (IL-6) | up to 90 days | Monitoring of patients' inflammatory marker |
| Rate of total oral feeding after the intervention | up to 90 days | 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. |
| Inflammation-related indicators: high mobility group box-1 protein (HMGB1) | up to 90 days | Monitoring of patients' inflammatory marker |
| Days of ICU hospitalization | up to 90 days | Days of ICU hospitalization |
| Total days of hospitalization | up to 90 days | Total days of hospitalization |
| In-hospital survival rate | up to 90 days | The number of patients who survive during hospitalization |
| Inflammation-related indicators: serum procalcitonin, acetylcholine (ACh) | up to 90 days | Monitoring of patients' inflammatory markers |
| Duration of Enteral Nutrition Tube Indwelling | up to 90 days | The duration of the nasogastric tube or nasointestinal tube indwelling in the patient |
Countries
China
Contacts
Primary ContactXiuqin Feng
Outcome results
None listed