Utilization of Negative Pressure Suction to Reduce Aspiration in Oropharyngeal Dysphagia

NCT ID: NCT03368079

Last Updated: 2025-03-28

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-30
• Study Completion Date: 2025-12-30

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

Conditions

Oropharyngeal Dysphagia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Negative Pressure Suction Device

Group Type: EXPERIMENTAL

Negative Pressure Suction Catheter

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, Davis

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

UC Davis Medical Center

Sacramento, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Randev Sandhu, BS

Role: CONTACT

rssandhu@ucdavis.edu

916-734-2863

Facility Contacts

Randev Sandhu, BS

Role: primary

rssandhu@ucdavis.edu

916-734-2863

Related Links

https://studypages.com/s/a-study-of-negative-pressure-suction-to-reduce-aspiration-inhaling-food-into-lungs-oropharyngeal-dysphagia-swallowing-disorder-672909/

Learn more or sign up for the study here!

Other Identifiers

836211

Identifier Type: -

Identifier Source: org_study_id