Using negative pressure suction to help patients with swallowing difficulties
Utilization of Negative Pressure Suction to Reduce Aspiration in Oropharyngeal Dysphagia
This study is testing if using negative pressure suction can help people with severe swallowing difficulties eat more safely and reduce the risk of aspiration and pneumonia.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of California, Davis Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Sacramento, California) |
| Trial ID | NCT03368079 on ClinicalTrials.gov |
What this trial studies
This study investigates whether applying negative pressure suction in the hypopharynx can reduce aspiration during swallowing in patients with oropharyngeal dysphagia. It focuses on individuals who have severe swallowing difficulties and are dependent on gastrostomy feeding tubes due to the risk of aspiration. The study will utilize Video Fluoroscopic Swallowing Exam (VFSE) to assess the effectiveness of this intervention. By examining the swallowing process, the researchers aim to determine if this method can improve safety and reduce the risk of pneumonia associated with aspiration.
Who should consider this trial
Good fit: Ideal candidates are patients with videofluoroscopic evidence of aspiration and who are dependent on gastrostomy tubes.
Not a fit: Patients with complete PES stricture or those unable to follow commands may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the safety and quality of life for patients with severe swallowing difficulties.
How similar studies have performed: While this approach is novel, similar studies have shown promise in improving swallowing safety in dysphagia patients.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Sacramento, California
- UC Davis Medical Center — Sacramento, California, United States (Recruiting)
Study contacts
- Study coordinator: Randev Sandhu, BS
- Email: rssandhu@ucdavis.edu
- Phone: 916-734-2863
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.