Clinical Application of Comprehensive Intervention for PED Based on Neuroregulatory Mechanism

Post-extubation Dysphagia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06386159
• Other study ID #: 2023-1178
• Status: Recruiting
• Phase: N/A
• Start date: March 15, 2024
• Est. completion date: July 30, 2025

Study information

• Verified date: March 2024
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: Xiuqin Feng
• Phone: 13757119151
• Email: fengxiuqin[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 69
• Est. completion date: July 30, 2025
• Est. primary completion date: April 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Deglutition Disorders
• Post-extubation Dysphagia

Intervention

Other:
• Electrical vagus nerve stimulation
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.

Locations

Country	Name	City	State
China	Feng Xiuqin	Hangzhou

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	functional oral intake scale(FOIS)	FOIS consists of seven levels: ? Score 1, unable to eat orally at all; ? Score 2, dependent on tube feeding, minimum attempt to eat food or liquid; ? Score 3, dependent on tube feeding, taking single texture food or liquid orally; ? Score 4, completely oral intake of single texture food; ? score 5: fully oral intake of a variety of food textures, but with special preparation or compensation; ?6 points, completely oral feeding without special preparation, but with special food restriction; ?7 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
Primary	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	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
Secondary	Duration of Enteral Nutrition Tube Indwelling	The duration of the nasogastric tube or nasointestinal tube indwelling in the patient	up to 90 days
Secondary	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
Secondary	Incidence of aspiration within one week after extubation	Incidence of aspiration within one week after extubation	up to 90 days
Secondary	The incidence of aspiration pneumonia within one week after extubation	The incidence of aspiration pneumonia within one week after extubation	up to 90 days
Secondary	Inflammation-related indicators: serum C-reactive protein (CRP)	Monitoring of patients' inflammatory marker	up to 90 days
Secondary	Inflammation-related indicators: serum interleukin-6 (IL-6)	Monitoring of patients' inflammatory marker	up to 90 days
Secondary	Inflammation-related indicators: serum procalcitonin, acetylcholine (ACh)	Monitoring of patients' inflammatory markers	up to 90 days
Secondary	Inflammation-related indicators: high mobility group box-1 protein (HMGB1)	Monitoring of patients' inflammatory marker	up to 90 days
Secondary	Days of ICU hospitalization	Days of ICU hospitalization	up to 90 days
Secondary	Total days of hospitalization	Total days of hospitalization	up to 90 days
Secondary	In-hospital survival rate	The number of patients who survive during hospitalization	up to 90 days