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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
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ time from when bolus head first passes posterior nasal spine to time bolus head enters base of vallecula
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
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)
Trial Design
1Treatment groups
Experimental Treatment
Group I: Negative Pressure Suction DeviceExperimental Treatment1 Intervention
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Who is running the clinical trial?
University of California, DavisLead Sponsor
928 Previous Clinical Trials
4,721,008 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You currently have cancer.You rely on a feeding tube that goes through your stomach.You have tried all standard treatment options, including physical therapy, medication, and surgery.
Research Study Groups:
This trial has the following groups:- Group 1: Negative Pressure Suction Device
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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