Status:
RECRUITING
Utilization of Negative Pressure Suction to Reduce Aspiration in Oropharyngeal Dysphagia
Lead Sponsor:
University of California, Davis
Conditions:
Oropharyngeal Dysphagia
Eligibility:
All Genders
18+ years
Phase:
NA
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 Swallo...
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 i...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 30 2016
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2025
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT03368079
Start Date
January 30 2016
End Date
December 30 2025
Last Update
March 28 2025
Active Locations (1)
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1
UC Davis Medical Center
Sacramento, California, United States, 95817