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

NCT ID: NCT06006195

Last Updated: 2023-08-23

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-08-28
• Study Completion Date: 2030-12-31

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.

Conditions

Swallowing Contraction Strength

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

patients with dysphagia symptoms

patients with dysphagia symptoms

Intervention Type: OTHER

patients with dysphagia symptoms examined by high resolution impedance manometry

patients without dysphagia symptoms

patients without dysphagia symptoms

Intervention Type: OTHER

patients without dysphagia symptoms examined by high resolution impedance manometry

Interventions

patients with dysphagia symptoms

patients with dysphagia symptoms examined by high resolution impedance manometry

Intervention Type: OTHER

patients without dysphagia symptoms

patients without dysphagia symptoms examined by high resolution impedance manometry

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• age from 20 to 80 years

Exclusion Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Taiwan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

National Taiwan University Clinical Trial Center

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Chih-Min Liu, MD

Role: CONTACT

lewisliu@ntuh.gov.tw

_886-972652224

Chih-Jun Lai, MD

Role: CONTACT

littlecherrytw@gmail.com

+886-972652086

Other Identifiers

202306130RINB

Identifier Type: -

Identifier Source: org_study_id