Clinical Application of Comprehensive Intervention for PED Based on Neuroregulatory Mechanism

NCT06386159 | Recruiting

• 1 other identifier: 2023-1178
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

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

Keywords

post-extubation dysphagia, electrical stimulation

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (12)

• Rate of total oral feeding after the intervention

  up to 90 days

• Duration of Enteral Nutrition Tube Indwelling

  up to 90 days

• Rate of Re-intubation after Endotracheal Intubation

  up to 90 days

• Incidence of aspiration within one week after extubation

  up to 90 days

• The incidence of aspiration pneumonia within one week after extubation

  up to 90 days

Study Arms (3)

Control Group

NO INTERVENTION

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

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 Combined with Vagus Nerve Stimulation Group

EXPERIMENTAL

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

Interventions

Comprehensive Intervention or Comprehensive Intervention Combined with Electrical vagus nerve stimulation 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; Comprehensive Intervention Group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who met the diagnostic criteria of PED were changed to SSA score ≥24
• aged from 18 to 90 years old;
• oral or nasotracheal intubation for ≥48 hours;
• Clear mind
• Glasgow score ≥13 points, with good cooperation ability;
• There was no contraindication to oral feeding after extubation

You may not qualify if:

• 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.);
• history of reflux and aspiration;
• tracheotomy;
• isolation treatment due to respiratory infectious diseases;
• the presence of implantable electronic devices (e.g., pacemakers, cochlear implants);
• Traumatic vagus recurrent laryngeal nerve injury, history of vagus nerve surgery, or vagus nerve injury

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead
• Jinhua Municipal Central Hospital: collaborator

Study Sites (1)

Jinhua Municipal Central Hospital

Jinhua, China

RECRUITING

Central Study Contacts

Xiuqin Feng

CONTACT

13757119151; fengxiuqin@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2024
• First Posted: April 26, 2024
• Study Start: March 15, 2024
• Primary Completion: April 30, 2025
• Study Completion: July 30, 2025
• Last Updated: July 1, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)