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

Sponsor

National Taiwan University Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06006195

Collaborator

(none)

Enrollment

88.1

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Swallowing Contraction Strength	Other: patients with dysphagia symptoms Other: patients without dysphagia symptoms

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 Design

Study Type:

Observational

Anticipated Enrollment :

50 participants

Observational Model:

Case-Control

Time Perspective:

Cross-Sectional

Official Title:

Investigating the Correlation Between Dysphagia Symptoms and Swallowing Muscle Groups by High-Resolution Pharyngeal Manometry With Impedance, Along With the Associated Nutritional Assessment

Anticipated Study Start Date :

Aug 28, 2023

Anticipated Primary Completion Date :

Dec 31, 2028

Anticipated Study Completion Date :

Dec 31, 2030

Arms and Interventions

Arm	Intervention/Treatment
patients with dysphagia symptoms	Other: patients with dysphagia symptoms patients with dysphagia symptoms examined by high resolution impedance manometry
patients without dysphagia symptoms	Other: patients without dysphagia symptoms patients without dysphagia symptoms examined by high resolution impedance manometry

Arm

Intervention/Treatment

patients with dysphagia symptoms

Other: patients with dysphagia symptoms

patients with dysphagia symptoms examined by high resolution impedance manometry

patients without dysphagia symptoms

Other: patients without dysphagia symptoms

patients without dysphagia symptoms examined by high resolution impedance manometry

Outcome Measures

Primary Outcome Measures

UES peak pressure, mmHg [10 to 15 minutes]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

age from 20 to 80 years

Exclusion Criteria:

bleeding tendency
pregnancy
heart failure
chronic kidney disease

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

National Taiwan University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

National Taiwan University Clinical Trial Center, Principal Investigator, National Taiwan University Hospital

ClinicalTrials.gov Identifier:

NCT06006195

Other Study ID Numbers:

202306130RINB

First Posted:

Aug 23, 2023

Last Update Posted:

Aug 23, 2023

Last Verified:

Aug 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Deglutition Disorders

Study Results

No Results Posted as of Aug 23, 2023