Clinical Application of Comprehensive Intervention for PED Based on Neuroregulatory Mechanism

Clinical Application of Comprehensive Intervention Scheme for Post-extubation Dysphagia Based on Neuroregulatory Mechanism

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.

Study Overview

• Status: Recruiting
• Conditions: Post-extubation Dysphagia
• Intervention / Treatment: Other: Comprehensive Intervention or Comprehensive Intervention Combined with Electrical vagus nerve stimulation

• Study Type: Interventional
• Enrollment (Estimated): 69
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xiuqin Feng; Phone Number: 13757119151; Email: fengxiuqin@zju.edu.cn

Study Locations

• China
  • Jinhua, China
    • Recruiting
    • Jinhua Municipal Central Hospital
    • Contact: Haiping Xu; Phone Number: 13506587812; Email: 240931013@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: 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.
Active Comparator: 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.	Other: 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.
Experimental: 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.	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
functional oral intake scale（FOIS）	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	up to 90 days
standardized Swallowing Assessment（SSA）	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.	up to 90 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of total oral feeding after the intervention	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.	up to 90 days
Duration of Enteral Nutrition Tube Indwelling	The duration of the nasogastric tube or nasointestinal tube indwelling in the patient	up to 90 days
Rate of Re-intubation after Endotracheal Intubation	The rate of re-intubation during the intervention period after extubation in patients who have undergone endotracheal intubation	up to 90 days
Incidence of aspiration within one week after extubation	Incidence of aspiration within one week after extubation	up to 90 days
The incidence of aspiration pneumonia within one week after extubation	The incidence of aspiration pneumonia within one week after extubation	up to 90 days
Inflammation-related indicators: serum C-reactive protein (CRP)	Monitoring of patients' inflammatory marker	up to 90 days
Inflammation-related indicators: serum interleukin-6 (IL-6)	Monitoring of patients' inflammatory marker	up to 90 days
Inflammation-related indicators: serum procalcitonin, acetylcholine (ACh)	Monitoring of patients' inflammatory markers	up to 90 days
Inflammation-related indicators: high mobility group box-1 protein (HMGB1)	Monitoring of patients' inflammatory marker	up to 90 days
Days of ICU hospitalization	Days of ICU hospitalization	up to 90 days
Total days of hospitalization	Total days of hospitalization	up to 90 days
In-hospital survival rate	The number of patients who survive during hospitalization	up to 90 days

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Collaborators: Jinhua Municipal Central Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2024
• Primary Completion (Estimated): April 30, 2025
• Study Completion (Estimated): July 30, 2025

Study Registration Dates

• First Submitted: April 24, 2024
• First Submitted That Met QC Criteria: April 25, 2024
• First Posted (Actual): April 26, 2024

Study Record Updates

• Last Update Posted (Actual): July 1, 2024
• Last Update Submitted That Met QC Criteria: June 28, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: post-extubation dysphagia, electrical stimulation
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Esophageal Diseases; Deglutition Disorders
• Other Study ID Numbers: 2023-1178

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No