Comprehensive intervention for swallowing difficulties after extubation
Clinical Application of Comprehensive Intervention Scheme for Post-extubation Dysphagia Based on Neuroregulatory Mechanism
This study is testing a new program to help adults in the ICU who have trouble swallowing after being taken off a ventilator, using expert advice and a special treatment that stimulates a nerve involved in swallowing.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 69 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | Second Affiliated Hospital, School of Medicine, Zhejiang University Academic / other |
| Locations | 1 site (Jinhua) |
| Trial ID | NCT06386159 on ClinicalTrials.gov |
What this trial studies
This study aims to create a comprehensive intervention program for patients experiencing post-extubation dysphagia (PED) in the ICU. It utilizes expert panel discussions and the Delphi method to establish best practices for assessment and intervention. The program incorporates vagus nerve stimulation based on preliminary experimental results, focusing on the neural regulation mechanisms involved in swallowing. The effectiveness of this intervention will be evaluated through clinical application in adult patients.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 90 who have experienced intubation for at least 48 hours and meet the diagnostic criteria for post-extubation dysphagia.
Not a fit: Patients with other conditions affecting swallowing, such as stroke or Parkinson's disease, or those with contraindications to oral feeding will not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve swallowing function and quality of life for patients recovering from intubation.
How similar studies have performed: While this approach is innovative, similar studies utilizing neural regulation mechanisms have shown promise in improving swallowing function.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Jinhua
- Jinhua Municipal Central Hospital — Jinhua, China (Recruiting)
Study contacts
- Study coordinator: Xiuqin Feng
- Email: fengxiuqin@zju.edu.cn
- Phone: 13757119151
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.