CompletedNot Applicable

Utilization of Negative Pressure Suction to Reduce Aspiration in Oropharyngeal Dysphagia

United States1 participantsStarted 2016-01-30

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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) Exclusion Criteria: * 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

What they're measuring

Degree of aspiration

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

Pharyngo-esophageal Segment (PES) opening size

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

Trial details

NCT IDNCT03368079

SponsorUniversity of California, Davis

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2016-04-13

View on ClinicalTrials.gov More Oropharyngeal Dysphagia trials