Clinical trial NCT03368079: Utilization of Negative Pressure Suction to Reduce Aspiration in Oropharyngeal Dysphagia
Official title: Utilization of Negative Pressure Suction to Reduce Aspiration in Oropharyngeal Dysphagia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Oropharyngeal Dysphagia
Keywords: Dysphagia
Oropharyngeal dysphagia
Video Fluoroscopic Swallowing Exam (VFSE)
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2017-12-11
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

Detailed 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

Eligibility criteria: 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

Primary outcomes:
measure: Degree of aspiration
timeFrame: During VFSE, from the beginning of administration of the first bolus size to completion of the VFSE
measure: 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.
Secondary outcomes:
measure: Pharyngeal Constriction Ratio (PCR)
timeFrame: 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.
measure: Oropharyngeal transit time
timeFrame: Time from when bolus head first passes posterior nasal spine to time bolus head enters base of vallecula
measure: Hypopharyngeal transit time
timeFrame: Time from when bolus head exits the vallecula to time when bolus tale exits PES
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: UC Davis Medical Center
state: California
Study officials:
References: