Correlation Between the HRIM and VFSS

Swallowing Disorder Clinical Trial

Official title:

The Correlation Between High Resolution Impedance Manometry and Videofluoroscopic Measurements of Swallowing Function in Cervical Spine Patients With Dysphagia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04591665
• Other study ID #: 202008024RINC
• Status: Completed
• Start date: November 5, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: October 2020
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

In many cases, the manometric examination is not feasible because of the pharyngeal sinusitis or pharyngeal torsion. In addition, although previous conventional manometry was used to estimate pharyngeal swallowing, the bolus flow transmission was still not evaluated, which still depended on the videofluoscopic swallowing studies. High resolution impedance manometry could help us to measure the bolus flow according to the impedance changes. However, the comparison between two approach methods of postoperative recovery of swallowing function is still inconclusive. The investigator aimed to examine the correlation between high-resolution manometric and videofluoroscopic measurements of the swallowing function.

Description:

Background: In many cases, the manometric examination is not feasible because of the pharyngeal sinusitis or pharyngeal torsion. In addition, although previous conventional manometry was used to estimate pharyngeal swallowing, the bolus flow transmission was still not evaluated, which still depended on the videofluoscopic swallowing studies. High resolution impedance manometry could help us to measure the bolus flow according to the impedance changes. However, the comparison between two approach methods of postoperative recovery of swallowing function is still inconclusive.

Objectives: The objective of the current study was to examine the correlation between high-resolution manometric and videofluoroscopic measurements of the swallowing function.

Patients and methods: Consecutive patients who will fulfill the criteria of postoperative cervical spine surgery patients aged >= 20 will be enrolled and the dysphagia questionnaire score (EAT-10) was higher than 3, including 3. After got the inform consent, these patients receive the swallowing function by videofluroscopy and HRIM.

Expected result: The investigator will evaluate the swallowing changes of these postoperative cervical spine patients with suspected dysphagia. The investigator expected that the highly correlation between the HRIM and VFSS.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: December 31, 2022
• Est. primary completion date: November 8, 2022
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

• > 20 years old

• postoperative cervical spine surgery

• EAT-10 questionnaire

Exclusion Criteria:

• pregnancy

• bleeding tendency

• heart or lung failure

Related Conditions & MeSH terms

• Deglutition Disorders
• Swallowing Disorder

Intervention

Other:
• swallowing examination
patients received swallowing examination, including high resolution impedance manometry and Video-Fluoroscopic swallowing study.

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pharyngeal pressure	the muscle power of pharyngeal contractility	15 minutes