Negative Pressure Suction for Oropharyngeal Dysphagia

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of California, Davis

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

Eligibility Criteria

This trial is for patients with oropharyngeal dysphagia who have a high risk of food entering their airway, rely on tube feeding, and haven't improved with standard treatments. It's not for those with severe throat narrowing, cognitive issues preventing cooperation, active cancer, no feeding tube, or recent cancer survivors.

Inclusion Criteria

Patients with videofluoroscopic evidence of aspiration with Rosenbek Penetration Aspiration Scale (PAS) greater than 5 for all tested food consistencies

You rely on a feeding tube that goes through your stomach.

You have tried all standard treatment options, including physical therapy, medication, and surgery.

Exclusion Criteria

No gastrostomy tube present

Inability to follow commands

Vulnerable populations: adults unable to consent, pregnant women, and prisoners

See 3 more

Treatment Details

Interventions

Negative Pressure Suction Catheter (Other)

Trial OverviewThe study tests if using a negative pressure suction catheter in the throat can reduce aspiration (food going into the lungs) during swallowing exams in people with difficulty swallowing.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Negative Pressure Suction DeviceExperimental Treatment1 Intervention