Clinical Application of Comprehensive Intervention for PED Based on Neuroregulatory Mechanism (NCT06386159) | Clinical Trial Compass
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Clinical Application of Comprehensive Intervention for PED Based on Neuroregulatory Mechanism
China69 participantsStarted 2024-03-15
Plain-language 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.
Who can participate
Age range18 Years – 90 Years
SexALL
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Inclusion criteria
✓. 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
Exclusion criteria
✕. 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;
What they're measuring
1
functional oral intake scale（FOIS）
Timeframe: up to 90 days
2
standardized Swallowing Assessment（SSA）
Timeframe: up to 90 days
Trial details
NCT IDNCT06386159
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University