Utilization of Negative Pressure Suction to Reduce Aspiration in Oropharyngeal Dysphagia

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.

Study Overview

• Status: Recruiting
• Conditions: Oropharyngeal Dysphagia
• Intervention / Treatment: Device: Negative Pressure Suction Catheter

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

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Randev Sandhu, BS; Phone Number: 916-734-2863; Email: rssandhu@ucdavis.edu

Study Locations

• United States
  • California
    • Sacramento, California, United States, 95817
      • Recruiting
      • UC Davis Medical Center
      • Contact: Randev Sandhu, BS; Phone Number: 916-734-2863; Email: rssandhu@ucdavis.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Negative Pressure Suction Device	Device: Negative Pressure Suction Catheter; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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: Material does not enter airway; Material enters the airway, remains above the vocal folds, and is ejected from the airway.; Material enters the airway, remains above the vocal folds, and is not ejected from the airway.; Material enters the airway, contacts the vocal folds, and is ejected from the airway.; Material enters the airway, contacts the vocal folds, and is not ejected from the airway.; Material enters the ariway, passes below the vocal folds, and is ejected into the larynx or out of the airway.; Material enters the airway, passes below the vocal folds, and is not ejected from the trachea despite effort.; 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharyngeal Constriction Ratio (PCR)	Pharyngeal Constriction Ratio: is a measure of pharyngeal clearance pressure. It is calculated by dividing the lateral pharyngeal area during maximal contraction by the area with a 1 cc bolus held in the oral cavity. The area is determined by onscreen tool provided. Normal PCR: 0.14 +/- 0.28	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	Oropharyngeal transit time is measured when the patient administers 20 cc of liquid barium. Normal oropharyngeal transit time: 0.42 sec +/- 0.36 sec	Time from when bolus head first passes posterior nasal spine to time bolus head enters base of vallecula
Hypopharyngeal transit time	Hypopharyngeal transit time: is measured when the patient administers 20 cc of liquid barium. Normal Hypopharyngeal transit time: 0.77 sec +/- 0.26 sec	Time from when bolus head exits the vallecula to time when bolus tale exits PES

Collaborators and Investigators

• Sponsor: University of California, Davis

Publications and helpful links

Helpful Links

• Learn more or sign up for the study here!

Study record dates

Study Major Dates

• Study Start: January 30, 2016
• Primary Completion (Estimated): December 30, 2023
• Study Completion (Estimated): December 30, 2023

Study Registration Dates

• First Submitted: October 29, 2017
• First Submitted That Met QC Criteria: December 4, 2017
• First Posted (Actual): December 11, 2017

Study Record Updates

• Last Update Posted (Actual): May 31, 2023
• Last Update Submitted That Met QC Criteria: May 30, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Dysphagia; Oropharyngeal dysphagia; Video Fluoroscopic Swallowing Exam (VFSE)
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Esophageal Diseases; Deglutition Disorders
• Other Study ID Numbers: 836211

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No