Investigating the Correlations Between Dysphagia Symptoms and Swallowing Muscle Groups by HRPM-I

Not yet recruiting

• Conditions: Swallowing Contraction Strength
• Interventions: Other: patients without dysphagia symptoms; Other: patients with dysphagia symptoms

• Registration Number: NCT06006195
• Lead Sponsor: National Taiwan University Hospital

Brief Summary

Investigating the correlation between the dysphagia symptoms and swallowing muscle groups by high resolution pharyngeal manometry with impedance

Detailed Description

Backgrounds: Some patients would experience dysphagia symptoms before the elective surgery. These patients usually do not have a history of head and neck surgery or cerebrovascular diseases. They are common causes of dysphagia. The anesthetics and airway manipulation can exacerbate dysphagia. However, research is limited on the specific weak muscle groups in patients with dysphagia symptoms, as well as on the existence of associated malnutrition.

Aims: The Eating Assessment Tool (EAT-10) questionnaire will be used to assess dysphagia symptoms. A score of ≥4 on the EAT-10 indicates the presence of dysphagia symptoms, while a score of \<4 indicates the absence. This study aims to (1) investigate which specific muscle groups are particularly weak in patients with dysphagia symptoms (EAT-10≥4); (2) to examine whether patients with dysphagia symptoms (EAT-10≥4) have poorer nutritional status than patients without dysphagia symptoms (EAT-10\<4).

Methods: This is a cross-sectional study. The investigators will recruit patients undergoing elective orthopedic surgery on the lower extremities, with the age range of 18 to 90 years. On the day of admission, patients will be examined by the EAT-10 questionnaire for dysphagia symptoms. High-resolution pharyngeal manometry with impedance will be conducted to measure the functional of swallowing muscles. Additionally, patients will be given the Mini Nutritional Assessment (MNA) questionnaire (a total score of 30 points). The higher scores indicate the better nutritional status. The albumin level will also be collected. The bioelectrical impedance analysis will be used to measure the patients' body composition, specifically skeletal muscle mass.

Study Timeline

• Status Verified: 2023-08
• Study First Submitted: 2023-08-06
• Study First Submitted QC: 2023-08-21
• Last Update Submitted: 2023-08-21
• Study First Posted: 2023-08-23
• Last Update Posted: 2023-08-23
• Study Start: 2023-08-28
• Primary Completion: 2028-12-31
• Study Completion: 2030-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• age from 20 to 80 years

Exclusion Criteria

• bleeding tendency
• pregnancy
• heart failure
• chronic kidney disease

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
patients without dysphagia symptoms	patients without dysphagia symptoms	-
patients with dysphagia symptoms	patients with dysphagia symptoms	-

Primary Outcome Measures

Name	Time	Method
UES peak pressure, mmHg	10 to 15 minutes