Utilization of Negative Pressure Suction to Reduce Aspiration in Oropharyngeal Dysphagia

  • STATUS
    Recruiting
  • End date
    Dec 30, 2023
  • participants needed
    10
  • sponsor
    University of California, Davis
Updated on 23 March 2022

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.

Description

During a properly coordinated swallow, the oropharynx, larynx, and hypopharynx undergo a series of movements that serve to prepare and expand the pharyngoesophageal segment (PES), which is the inlet into the esophagus. Under normal circumstances, a food bolus is safely propelled from the oropharynx, through the PES, and into the esophagus. Surgical and radiation therapy in the head and neck, as well as deficiencies such as poor coordination, mistiming, or obstructing lesions may prevent the food bolus from safely entering the esophagus and instead diverting toward the trachea.

A number of patients with severe oropharyngeal dysphagia are not able to tolerate any diet without risking aspiration and subsequent pneumonia, often to a degree severe enough that they cannot manage to safely swallow their secreted saliva. These patients depend on a gastrostomy feeding tube in order to obtain adequate daily nutritional requirements and must suction or spit out their saliva to prevent aspiration and a sensation of asphyxiation. Despite these precautions, many of these patients ultimately suffer life-threatening pneumonia. Investigators will be testing if the use of use of a negative pressure suction in the hypopharynx will reduce the amount of aspiration during Video Fluoroscopic Swallowing Exam (VFSE) among patients with severe oropharyngeal dysphagia

Details
Condition Oropharyngeal Dysphagia
Treatment Negative pressure suction catheter
Clinical Study IdentifierNCT03368079
SponsorUniversity of California, Davis
Last Modified on23 March 2022

Eligibility

Yes No Not Sure

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
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