NCT03368079

Brief Summary

This is an investigator initiated prospective study to determine whether the use of a negative pressure suction in the hypopharynx will reduce the amount of aspiration during Video Fluoroscopic Swallowing Exam (VFSE) among patients with oropharyngeal dysphagia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2016

Longer than P75 for not_applicable

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

Study Start

First participant enrolled

January 30, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 13, 2016

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

October 29, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 11, 2017

Completed
8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 9, 2025

Completed
Last Updated

April 9, 2026

Status Verified

April 1, 2026

Enrollment Period

2 months

First QC Date

October 29, 2017

Last Update Submit

April 3, 2026

Conditions

Oropharyngeal Dysphagia

Keywords

DysphagiaOropharyngeal dysphagiaVideo Fluoroscopic Swallowing Exam (VFSE)

Outcome Measures

Primary Outcomes (2)

  • Degree of aspiration

    Degree of aspiration or laryngeal penetration, evaluated by the validated Rosenbek Penetration-Aspiration Scale (PAS). The PAS scale is an 8-point (1 to 8), equal-appearing interval scale: 1. Material does not enter airway 2. Material enters the airway, remains above the vocal folds, and is ejected from the airway. 3. Material enters the airway, remains above the vocal folds, and is not ejected from the airway. 4. Material enters the airway, contacts the vocal folds, and is ejected from the airway. 5. Material enters the airway, contacts the vocal folds, and is not ejected from the airway. 6. Material enters the ariway, passes below the vocal folds, and is ejected into the larynx or out of the airway. 7. Material enters the airway, passes below the vocal folds, and is not ejected from the trachea despite effort. 8. Material enters the airway, passes below the vocal folds, and no effort is made to eject.

    During VFSE, from the beginning of administration of the first bolus size to completion of the VFSE

  • Pharyngo-esophageal Segment (PES) opening size

    Pharyngo-esophageal Segment (PES) is a 2.5 to 4.5 cm manometric high-pressure zone located between the pharynx and esophagus. Normal Pharyngoesophageal segment opening size on lateral view: 0.80 cm +/- 0.40 cm

    During VFSE, PES is measured when the patient administers 20 cc of liquid barium and the PES is maximally distended.

Secondary Outcomes (3)

  • Pharyngeal Constriction Ratio (PCR)

    Measurement of the pharyngeal area during maximum contraction are taken after administration of 20 cc liquid barium. The pharyngeal area at rest is measured when 1 cc bolus is held in the oral cavity.

  • Oropharyngeal transit time

    Time from when bolus head first passes posterior nasal spine to time bolus head enters base of vallecula

  • Hypopharyngeal transit time

    Time from when bolus head exits the vallecula to time when bolus tale exits PES

Study Arms (1)

Negative Pressure Suction Device

EXPERIMENTAL
Device: Negative Pressure Suction Catheter

Interventions

Negative Pressure Suction CatheterDEVICE

The negative pressure suction device to be used in the study will be a Foley catheter. The catheter will be placed through the gastrostomy tube site, directed retrograde through the esophagus, and terminating in the PES.

Negative Pressure Suction Device

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with videofluoroscopic evidence of aspiration with Rosenbek Penetration Aspiration Scale (PAS) greater than 5 for all tested food consistencies
  • Gastrostomy tube dependence
  • Exhaustion of conventional treatment options (physical, medical, and surgical therapies)

You may not qualify if:

  • Complete PES stricture
  • Inability to follow commands
  • Current malignant disease
  • No gastrostomy tube present
  • Less than two years of cancer-free survival (if applicable)
  • Vulnerable populations: adults unable to consent, pregnant women, and prisoners

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UC Davis Medical Center

Sacramento, California, 95817, United States

Location

Related Links

MeSH Terms

Conditions

Deglutition Disorders

Condition Hierarchy (Ancestors)

Esophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesPharyngeal DiseasesOtorhinolaryngologic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 29, 2017

First Posted

December 11, 2017

Study Start

January 30, 2016

Primary Completion

April 13, 2016

Study Completion

December 9, 2025

Last Updated

April 9, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)