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NCT Number: NCT06006195

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

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

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Key information

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • age from 20 to 80 years

Exclusion criteria

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

Treatment and study plan

patients with dysphagia symptoms

Other

patients with dysphagia symptoms examined by high resolution impedance manometry

patients without dysphagia symptoms

Other

patients without dysphagia symptoms examined by high resolution impedance manometry

Primary outcomes

  1. UES peak pressure, mmHg

    Time frame: 10 to 15 minutes

Study contacts

Contact information is provided by the study sponsor or research team.

Chih-Jun Lai, MD

CONTACT

[email protected]

+886-972652086

Chih-Min Liu, MD

CONTACT

[email protected]

_886-972652224

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2028
Study completion
2030
First posted
Aug 23, 2023
Registry last updated
Aug 23, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.