Clinical Application of Comprehensive Intervention for PED Based on Neuroregulatory Mechanism

Zhejiang University

Status: Enrolling

Conditions: Post-extubation Dysphagia

Treatments: Other: Comprehensive Intervention or Comprehensive Intervention Combined with Electrical vagus nerve stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT06386159

2023-1178

Details and patient eligibility

About

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.

Enrollment: 69 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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69 participants in 3 patient groups

Control Group

No Intervention group

Description:

During routine medical care and nursing, the responsible nurse provides daily oral care and delivers health education to patients and their caregivers regarding diet and swallowing safety. Within 8 hours after the removal of the endotracheal tube, the Standardized Swallowing Assessment (SSA) is used to screen for swallowing function. Patients are guided in food selection based on the severity of their swallowing difficulties and personal preferences, and are supplemented with enteral or parenteral nutrition or prescribed specific diets as directed by their doctor.

Comprehensive Intervention Group

Active Comparator group

Description:

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.

Treatment:

Other: Comprehensive Intervention or Comprehensive Intervention Combined with Electrical vagus nerve stimulation

Comprehensive Intervention Combined with Vagus Nerve Stimulation Group

Experimental group

Description:

On the basis of the control group, a comprehensive intervention is implemented in combination with vagus nerve electrical stimulation.

Treatment:

Other: Comprehensive Intervention or Comprehensive Intervention Combined with Electrical vagus nerve stimulation