Oropharyngeal DysphagiaNCT03368079
Utilization of Negative Pressure Suction to Reduce Aspiration in Oropharyngeal Dysphagia
A study testing Negative Pressure Suction Catheter in people with Oropharyngeal Dysphagia, run by University of California, Davis at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oropharyngeal Dysphagia
- What is being tested?
- Negative Pressure Suction Catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jan 2016to 9 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
UC Davis Medical Center
Sacramento, California, 95817
About this study
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.
Read the detailed description
During a properly coordinated swallow, the oropharynx, larynx, and hypopharynx undergo a series of movements that serve to prepare and expand the pharyngoesophageal segment (PES), which is the inlet into the esophagus. Under normal circumstances, a food bolus is safely propelled from the oropharynx, through the PES, and into the esophagus. Surgical and radiation therapy in the head and neck, as well as deficiencies such as poor coordination, mistiming, or obstructing lesions may prevent the food bolus from safely entering the esophagus and instead diverting toward the trachea.
A number of patients with severe oropharyngeal dysphagia are not able to tolerate any diet without risking aspiration and subsequent pneumonia, often to a degree severe enough that they cannot manage to safely swallow their secreted saliva. These patients depend on a gastrostomy feeding tube in order to obtain adequate daily nutritional requirements and must suction or spit out their saliva to prevent aspiration and a sensation of asphyxiation. Despite these precautions, many of these patients ultimately suffer life-threatening pneumonia. Investigators will be testing if the use of use of a negative pressure suction in the hypopharynx will reduce the amount of aspiration during Video Fluoroscopic Swallowing Exam (VFSE) among patients with severe oropharyngeal dysphagia
- Conditions
- Oropharyngeal Dysphagia
- Being tested
- Negative Pressure Suction Catheter
- Keywords
- Dysphagia, Oropharyngeal dysphagia, Video Fluoroscopic Swallowing Exam (VFSE)
- Medical subject headings
- Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Negative Pressure Suction CatheterDevice
The negative pressure suction device to be used in the study will be a Foley catheter. The catheter will be placed through the gastrostomy tube site, directed retrograde through the esophagus, and terminating in the PES.
| Study group | Role | What they receive |
|---|---|---|
| Negative Pressure Suction Device | Experimental | Not described Receives: Device: Negative Pressure Suction Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of aspiration
Degree of aspiration or laryngeal penetration, evaluated by the validated Rosenbek Penetration-Aspiration Scale (PAS). The PAS scale is an 8-point (1 to 8), equal-appearing interval scale:
- Material does not enter airway
- Material enters the airway, remains above the vocal folds, and is ejected from the airway.
- Material enters the airway, remains above the vocal folds, and is not ejected from the airway.
- Material enters the airway, contacts the vocal folds, and is ejected from the airway.
- Material enters the airway, contacts the vocal folds, and is not ejected from the airway.
- Material enters the ariway, passes below the vocal folds, and is ejected into the larynx or out of the airway.
- Material enters the airway, passes below the vocal folds, and is not ejected from the trachea despite effort.
- Material enters the airway, passes below the vocal folds, and no effort is made to eject.
Measured: During VFSE, from the beginning of administration of the first bolus size to completion of the VFSE
Pharyngo-esophageal Segment (PES) opening size
Pharyngo-esophageal Segment (PES) is a 2.5 to 4.5 cm manometric high-pressure zone located between the pharynx and esophagus. Normal Pharyngoesophageal segment opening size on lateral view: 0.80 cm +/- 0.40 cm
Measured: During VFSE, PES is measured when the patient administers 20 cc of liquid barium and the PES is maximally distended.
Secondary outcomes (3)
Pharyngeal Constriction Ratio (PCR)
Pharyngeal Constriction Ratio: is a measure of pharyngeal clearance pressure. It is calculated by dividing the lateral pharyngeal area during maximal contraction by the area with a 1 cc bolus held in the oral cavity. The area is determined by onscreen tool provided. Normal PCR: 0.14 +/- 0.28
Measured: 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.
Oropharyngeal transit time
Oropharyngeal transit time is measured when the patient administers 20 cc of liquid barium. Normal oropharyngeal transit time: 0.42 sec +/- 0.36 sec
Measured: Time from when bolus head first passes posterior nasal spine to time bolus head enters base of vallecula
Hypopharyngeal transit time
Hypopharyngeal transit time: is measured when the patient administers 20 cc of liquid barium. Normal Hypopharyngeal transit time: 0.77 sec +/- 0.26 sec
Measured: Time from when bolus head exits the vallecula to time when bolus tale exits PES
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2017
- Study start30 Jan 2016
- Primary completion13 Apr 2016
- Study completion9 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oropharyngeal DysphagiaStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03368079
- Sponsor's protocol ID
- 836211
- Status last verified
- Apr 2026
- First submitted
- 29 Oct 2017
- Last updated
- 9 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utilization of Negative Pressure Suction to Reduce Aspiration in Oropharyngeal Dysphagia
- ClinicalTrials.gov ID
- NCT03368079
- Acronym / sponsor ID
- 836211
- Conditions
- Oropharyngeal Dysphagia
- Keywords
- Dysphagia, Oropharyngeal dysphagia, Video Fluoroscopic Swallowing Exam (VFSE)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- 30 Jan 2016 (actual)
- Primary completion
- 13 Apr 2016 (actual)
- Study completion
- 9 Dec 2025 (actual)
- First posted
- 11 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
During a properly coordinated swallow, the oropharynx, larynx, and hypopharynx undergo a series of movements that serve to prepare and expand the pharyngoesophageal segment (PES), which is the inlet into the esophagus. Under normal circumstances, a food bolus is safely propelled from the oropharynx, through the PES, and into the esophagus. Surgical and radiation therapy in the head and neck, as well as deficiencies such as poor coordination, mistiming, or obstructing lesions may prevent the food bolus from safely entering the esophagus and instead diverting toward the trachea.
A number of patients with severe oropharyngeal dysphagia are not able to tolerate any diet without risking aspiration and subsequent pneumonia, often to a degree severe enough that they cannot manage to safely swallow their secreted saliva. These patients depend on a gastrostomy feeding tube in order to obtain adequate daily nutritional requirements and must suction or spit out their saliva to prevent aspiration and a sensation of asphyxiation. Despite these precautions, many of these patients ultimately suffer life-threatening pneumonia. Investigators will be testing if the use of use of a negative pressure suction in the hypopharynx will reduce the amount of aspiration during Video Fluoroscopic Swallowing Exam (VFSE) among patients with severe oropharyngeal dysphagia
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Negative Pressure Suction Device | Experimental | Device: Negative Pressure Suction Catheter |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (6 listed)
- Complete PES stricture
- Inability to follow commands
- Current malignant disease
- No gastrostomy tube present
- Less than two years of cancer-free survival (if applicable)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Negative Pressure Suction CatheterThe negative pressure suction device to be used in the study will be a Foley catheter. The catheter will be placed through the gastrostomy tube site, directed retrograde through the esophagus, and terminating in the PES. | Device | Negative Pressure Suction Device |
Primary outcome
Degree of aspiration
Time frame: During VFSE, from the beginning of administration of the first bolus size to completion of the VFSE
Degree of aspiration or laryngeal penetration, evaluated by the validated Rosenbek Penetration-Aspiration Scale (PAS). The PAS scale is an 8-point (1 to 8), equal-appearing interval scale: 1. Material does not enter airway 2. Material enters the airway, remains above the vocal folds, and is ejected from the airway. 3. Material enters the airway, remains above the vocal folds, and is not ejected from the airway. 4. Material enters the airway, contacts the vocal folds, and is ejected from the airway. 5. Material enters the airway, contacts the vocal folds, and is not ejected from the airway. 6. Material enters the ariway, passes below the vocal folds, and is ejected into the larynx or out of the airway. 7. Material enters the airway, passes below the vocal folds, and is not ejected from the trachea despite effort. 8. Material enters the airway, passes below the vocal folds, and no effort is made to eject.
Pharyngo-esophageal Segment (PES) opening size
Time frame: During VFSE, PES is measured when the patient administers 20 cc of liquid barium and the PES is maximally distended.
Pharyngo-esophageal Segment (PES) is a 2.5 to 4.5 cm manometric high-pressure zone located between the pharynx and esophagus. Normal Pharyngoesophageal segment opening size on lateral view: 0.80 cm +/- 0.40 cm
3 secondary outcomes
Pharyngeal Constriction Ratio (PCR)
Time frame: 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.
Oropharyngeal transit time
Time frame: Time from when bolus head first passes posterior nasal spine to time bolus head enters base of vallecula
Hypopharyngeal transit time
Time frame: Time from when bolus head exits the vallecula to time when bolus tale exits PES
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2026.
- Learn more or sign up for the study here!Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Negative Pressure Suction Catheter in people with Oropharyngeal Dysphagia, run by University of California, Davis at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Degree of aspiration (time frame: During VFSE, from the beginning of administration of the first bolus size to completion of the VFSE). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2026.