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Negative Pressure Suction for Oropharyngeal Dysphagia

N/A
Recruiting
Research Sponsored by University of California, Davis
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 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.
Awards & highlights
No Placebo-Only Group

Summary

This trial will test whether using a suction device during a swallowing exam can help prevent aspiration among patients with difficulty swallowing.

Who is the study for?
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.
What is being tested?
The 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.
What are the potential side effects?
Potential side effects may include discomfort from the catheter placement and possible irritation to the throat area due to suction.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~time from when bolus head first passes posterior nasal spine to time bolus head enters base of vallecula
This trial's timeline: 3 weeks for screening, Varies for treatment, and time from when bolus head first passes posterior nasal spine to time bolus head enters base of vallecula for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Degree of aspiration
Pharyngo-esophageal Segment (PES) opening size
Secondary study objectives
Hypopharyngeal transit time
Oropharyngeal transit time
Pharyngeal Constriction Ratio (PCR)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Negative Pressure Suction DeviceExperimental Treatment1 Intervention

Find a Location

Who is running the clinical trial?

University of California, DavisLead Sponsor
946 Previous Clinical Trials
4,756,120 Total Patients Enrolled

Media Library

Negative Pressure Suction Catheter (Other) Clinical Trial Eligibility Overview. Trial Name: NCT03368079 — N/A
Oropharyngeal Dysphagia Research Study Groups: Negative Pressure Suction Device
Oropharyngeal Dysphagia Clinical Trial 2023: Negative Pressure Suction Catheter Highlights & Side Effects. Trial Name: NCT03368079 — N/A
Negative Pressure Suction Catheter (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03368079 — N/A
~0 spots leftby Dec 2024
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