NCT04591665

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 6, 2020

Completed
13 days until next milestone

First Posted

Study publicly available on registry

October 19, 2020

Completed
17 days until next milestone

Study Start

First participant enrolled

November 5, 2020

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 8, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

May 14, 2025

Status Verified

October 1, 2020

Enrollment Period

2 years

First QC Date

October 6, 2020

Last Update Submit

May 11, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • pharyngeal pressure

    the muscle power of pharyngeal contractility

    15 minutes

Interventions

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

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • pregnancy
  • bleeding tendency
  • heart or lung failure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, 10002, Taiwan

Location

MeSH Terms

Conditions

Deglutition Disorders

Condition Hierarchy (Ancestors)

Esophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesPharyngeal DiseasesOtorhinolaryngologic Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 6, 2020

First Posted

October 19, 2020

Study Start

November 5, 2020

Primary Completion

November 8, 2022

Study Completion

December 31, 2022

Last Updated

May 14, 2025

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

ethical concern

Locations