Clinical Application of Comprehensive Intervention for PED Based on Neuroregulatory Mechanism
- Conditions
- Post-extubation Dysphagia
- Interventions
- Other: Comprehensive Intervention or Comprehensive Intervention Combined with Electrical vagus nerve stimulation
- Registration Number
- NCT06386159
- Lead Sponsor
- Second Affiliated Hospital, School of Medicine, Zhejiang University
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 69
- Patients who met the diagnostic criteria of PED were changed to SSA score ≥24
- aged from 18 to 90 years old;
- oral or nasotracheal intubation for ≥48 hours;
- Clear mind
- Glasgow score ≥13 points, with good cooperation ability;
- There was no contraindication to oral feeding after extubation
- 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.);
- history of reflux and aspiration;
- tracheotomy;
- isolation treatment due to respiratory infectious diseases;
- the presence of implantable electronic devices (e.g., pacemakers, cochlear implants);
- Traumatic vagus recurrent laryngeal nerve injury, history of vagus nerve surgery, or vagus nerve injury
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Comprehensive Intervention Group Comprehensive Intervention or Comprehensive Intervention Combined with Electrical vagus nerve stimulation On the basis of the control group, a comprehensive intervention plan determined through Delphi expert consultation is implemented for PED patients. This plan includes multidisciplinary collaboration, screening and assessment, oral sensory training, oral motor training, respiratory training, and feeding management. The duration and frequency of the exercises are tailored to the patient's actual condition. Comprehensive Intervention Combined with Vagus Nerve Stimulation Group Comprehensive Intervention or Comprehensive Intervention Combined with Electrical vagus nerve stimulation On the basis of the control group, a comprehensive intervention is implemented in combination with vagus nerve electrical stimulation.
- Primary Outcome Measures
Name Time Method 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.
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
- Secondary Outcome Measures
Name Time Method 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: serum procalcitonin, acetylcholine (ACh) up to 90 days Monitoring of patients' inflammatory markers
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
Inflammation-related indicators: serum interleukin-6 (IL-6) up to 90 days Monitoring of patients' inflammatory marker
Inflammation-related indicators: high mobility group box-1 protein (HMGB1) up to 90 days Monitoring of patients' inflammatory marker
Duration of Enteral Nutrition Tube Indwelling up to 90 days The duration of the nasogastric tube or nasointestinal tube indwelling in the patient
Inflammation-related indicators: serum C-reactive protein (CRP) up to 90 days Monitoring of patients' inflammatory marker
Total days of hospitalization up to 90 days Total days of hospitalization
The incidence of aspiration pneumonia within one week after extubation up to 90 days The incidence of aspiration pneumonia within one week after extubation
In-hospital survival rate up to 90 days The number of patients who survive during hospitalization
Days of ICU hospitalization up to 90 days Days of ICU hospitalization
Trial Locations
- Locations (1)
Jinhua Municipal Central Hospital
🇨🇳Jinhua, China