Negative Pressure Suction for Oropharyngeal Dysphagia

Overseen By Randev Sandhu, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, Davis

Disqualifiers: Complete PES stricture, Malignant disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1-2 weeks

10 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to assist individuals with oropharyngeal dysphagia, a condition that causes difficulty swallowing. Researchers aim to determine if a special suction device, the Negative Pressure Suction Catheter, can reduce the risk of food or liquid entering the airway during a swallowing test. This device targets those who rely on a feeding tube and have not found success with other treatments. Participants should have demonstrated swallowing difficulties in tests and already use a gastrostomy tube for feeding. Those who have exhausted all conventional treatments and meet these criteria might be suitable for this study. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could lead to new treatment options for swallowing difficulties.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this negative pressure suction device is safe for oropharyngeal dysphagia?

Research has shown that negative pressure suction—a method that clears the throat by creating a vacuum—might be safe for individuals with swallowing difficulties. One study using a human body model (a cadaver) demonstrated that this technique reduced the risk of aspiration without causing harm, suggesting general safety.

Another study examined devices similar to the one being tested and found them useful in emergencies. They resolved choking incidents in 38 patients, with all patients surviving. This indicates that suction can be effective and safe when performed correctly.

Overall, these findings suggest the treatment is likely well-tolerated. However, prospective trial participants should consult their healthcare provider about potential risks and benefits. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Negative Pressure Suction is unique because it introduces a new method for managing oropharyngeal dysphagia by using a suction catheter to create negative pressure. This approach stands out from traditional treatments like swallowing therapy and dietary modifications, as it directly targets the mechanics of swallowing. Researchers are excited about this technique because it could offer a more immediate and mechanical solution to improve swallowing function, potentially benefiting those who haven't found success with existing therapies. Additionally, the device's non-invasive nature could make it a safer and more comfortable option for patients.

What evidence suggests that this negative pressure suction device is effective for oropharyngeal dysphagia?

Research has shown that negative pressure suction devices, which participants in this trial will use, may assist individuals with oropharyngeal dysphagia, a condition involving difficulty swallowing. In one study, a similar device helped 38 out of 39 adults with this issue. This technique, sometimes called "vacuum swallowing," uses gentle suction to ease the movement of food down the throat. Some studies have found this method to be quick and effective. These early results suggest that using a negative pressure suction device could reduce the risk of choking or food entering the airway during swallowing tests. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo Video Fluoroscopic Swallowing Exam (VFSE) with the use of a negative pressure suction device to reduce aspiration

1-2 weeks

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the VFSE treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Negative Pressure Suction Catheter

Trial Overview 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.

How Is the Trial Designed?

Group I: Negative Pressure Suction Device Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

University of California, Davis

Lead Sponsor

Trials

958

Recruited

4,816,000+

Published Research Related to This Trial

The LifeVac, a novel portable non-powered suction device, has been reported to successfully resuscitate 38 out of 39 adults with oropharyngeal dysphagia during choking emergencies over a 6-year period, indicating its potential efficacy in real-world situations.

The device presents a minimal risk and may serve as a valuable alternative for resuscitating choking patients when traditional methods like abdominal thrusts or back blows are ineffective.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of a Novel Portable Non-powered Suction Device in Patients With Oropharyngeal Dysphagia During a Choking Emergency. McKinley, MJ., Deede, J., Markowitz, B.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT03368079

Utilization of Negative Pressure Suction to Reduce ... 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 ...

2. withpower.com withpower.com/trial/negative-pressure-suction-for-oropharyngeal-dysphagia-b0576

Negative Pressure Suction for Oropharyngeal Dysphagia The LifeVac, a novel portable non-powered suction device, has been reported to successfully resuscitate 38 out of 39 adults with oropharyngeal dysphagia during ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11893715/

Efficacy and Safety of “Vacuum Swallowing” Based on a ... Vacuum swallowing is a unique method for improving the pharyngeal passage of a bolus by creating subatmospheric negative pressure in the esophagus.

4. sciencedirect.com sciencedirect.com/science/article/pii/S0031940625003177

The use of nasopharyngeal and oropharyngeal suctioning ... Moreover, respondents indicated that suctioning is quick (8/134, 11%), effective (4/134, 5%) and potentially could be lifesaving (3/134, 4%). Other reported ...

5. centerwatch.com centerwatch.com/clinical-trials/listings/NCT03368079/utilization-of-negative-pressure-suction-to-reduce-aspiration-in-oropharyngeal-dysphagia

Utilization of Negative Pressure Suction to Reduce ... 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 ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S1755599X25000059

A systematic review on suction-based airway clearance ... The device resolved the choking incident in 38 patients, with the patients surviving.

7. pedistat.com pedistat.com/blog/how-home-suction-devices-benefit-children-with-swallowing-difficulties

How home suction devices benefit children with swallowing ... A notable case series showcased a 97% resuscitation success rate for patients with oropharyngeal dysphagia using devices such as the LifeVac, ...