Clinical trial NCT06386159: Clinical Application of Comprehensive Intervention for PED Based on Neuroregulatory Mechanism
Official title: Clinical Application of Comprehensive Intervention Scheme for Post-extubation Dysphagia Based on Neuroregulatory Mechanism
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Post-extubation Dysphagia
Keywords: post-extubation dysphagia, electrical stimulation
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
Collaborators: name: Jinhua Municipal Central Hospital
First posted: 2024-04-26
Enrollment: 69
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: functional oral intake scale（FOIS）
timeFrame: up to 90 days
measure: standardized Swallowing Assessment（SSA）
timeFrame: up to 90 days
Secondary outcomes:
measure: Rate of total oral feeding after the intervention
timeFrame: up to 90 days
measure: Duration of Enteral Nutrition Tube Indwelling
timeFrame: up to 90 days
measure: Rate of Re-intubation after Endotracheal Intubation
timeFrame: up to 90 days
measure: Incidence of aspiration within one week after extubation
timeFrame: up to 90 days
measure: The incidence of aspiration pneumonia within one week after extubation
timeFrame: up to 90 days
measure: Inflammation-related indicators: serum C-reactive protein (CRP)
timeFrame: up to 90 days
measure: Inflammation-related indicators: serum interleukin-6 (IL-6)
timeFrame: up to 90 days
measure: Inflammation-related indicators: serum procalcitonin, acetylcholine (ACh)
timeFrame: up to 90 days
measure: Inflammation-related indicators: high mobility group box-1 protein (HMGB1)
timeFrame: up to 90 days
measure: Days of ICU hospitalization
timeFrame: up to 90 days
measure: Total days of hospitalization
timeFrame: up to 90 days
measure: In-hospital survival rate
timeFrame: up to 90 days
Other outcomes:
Locations:
city: Jinhua
country: China
facility: Jinhua Municipal Central Hospital
Study officials:
References: