Clinical Application of Comprehensive Intervention for PED Based on Neuroregulatory Mechanism

NCT ID: NCT06386159

Last Updated: 2024-07-01

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 69 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-15
• Study Completion Date: 2025-07-30

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.

Conditions

Post-extubation Dysphagia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Control Group

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Comprehensive Intervention Group

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.

Group Type: ACTIVE_COMPARATOR

Comprehensive Intervention or Comprehensive Intervention Combined with Electrical vagus nerve stimulation

Intervention Type: OTHER

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.

Comprehensive Intervention Combined with Vagus Nerve Stimulation Group

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

Group Type: EXPERIMENTAL

Comprehensive Intervention or Comprehensive Intervention Combined with Electrical vagus nerve stimulation

Intervention Type: OTHER

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.

Interventions

Comprehensive 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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jinhua Municipal Central Hospital

OTHER

Sponsor Role: collaborator

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Jinhua Municipal Central Hospital

Jinhua, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Xiuqin Feng

Role: CONTACT

fengxiuqin@zju.edu.cn

13757119151

Facility Contacts

Haiping Xu

Role: primary

240931013@qq.com

13506587812

Other Identifiers

2023-1178

Identifier Type: -

Identifier Source: org_study_id