Swallowing Difficult Sensation After Cervical Spine Surgery

May 11, 2025 updated by: National Taiwan University Hospital

Swallowing Changes in Cervical Spine Patients With Postoperative Dysphagia

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Actual)

43

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan, 10002
        • National Taiwan University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

patients after cervical spine surgery, EAT-10 and older than 20 years old

Description

Inclusion Criteria:

  • > 20 years old
  • postoperative cervical spine surgery
  • EAT-10 questionnaire

Exclusion Criteria:

  • pregnancy
  • bleeding tendency
  • heart or lung failure

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pharyngeal pressure
Time Frame: 15 minutes
the muscle power of pharyngeal contractility
15 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 5, 2020

Primary Completion (Actual)

November 8, 2022

Study Completion (Actual)

December 31, 2022

Study Registration Dates

First Submitted

October 6, 2020

First Submitted That Met QC Criteria

October 14, 2020

First Posted (Actual)

October 19, 2020

Study Record Updates

Last Update Posted (Actual)

May 14, 2025

Last Update Submitted That Met QC Criteria

May 11, 2025

Last Verified

October 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202008024RINC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

ethical concern

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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