Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Utilization of Negative Pressure Suction to Reduce Aspiration in Oropharyngeal Dysphagia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03368079
Recruitment Status : Recruiting
First Posted : December 11, 2017
Last Update Posted : June 13, 2019
Sponsor:
Information provided by (Responsible Party):
University of California, Davis

Brief 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.

Condition or disease Intervention/treatment Phase
Oropharyngeal Dysphagia Device: Negative Pressure Suction Catheter Not Applicable

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


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Utilization of Negative Pressure Suction to Reduce Aspiration in Oropharyngeal Dysphagia
Actual Study Start Date : March 30, 2016
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Negative Pressure Suction Device Device: Negative Pressure Suction Catheter
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.




Primary Outcome Measures :
  1. 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.

  2. 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


Secondary Outcome Measures :
  1. 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. ]
    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

  2. Oropharyngeal transit time [ Time Frame: Time from when bolus head first passes posterior nasal spine to time bolus head enters base of vallecula ]
    Oropharyngeal transit time is measured when the patient administers 20 cc of liquid barium. Normal oropharyngeal transit time: 0.42 sec +/- 0.36 sec

  3. Hypopharyngeal transit time [ Time Frame: Time from when bolus head exits the vallecula to time when bolus tale exits PES ]
    Hypopharyngeal transit time: is measured when the patient administers 20 cc of liquid barium. Normal Hypopharyngeal transit time: 0.77 sec +/- 0.26 sec



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03368079


Contacts
Layout table for location contacts
Contact: Ahmed Bayoumi, MB BCh 916-734-2863 hs-oto-study@ou.ad3.ucdavis.edu

Locations
Layout table for location information
United States, California
UC Davis Medical Center Recruiting
Sacramento, California, United States, 95817
Contact: Ahmed Bayoumi, MB BCh    916-734-2863    hs-oto-study@ou.ad3.ucdavis.edu   
Sponsors and Collaborators
University of California, Davis

Layout table for additonal information
Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT03368079     History of Changes
Other Study ID Numbers: 836211
First Posted: December 11, 2017    Key Record Dates
Last Update Posted: June 13, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by University of California, Davis:
Dysphagia
Oropharyngeal dysphagia
Video Fluoroscopic Swallowing Exam (VFSE)
Additional relevant MeSH terms:
Layout table for MeSH terms
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pharyngeal Diseases
Otorhinolaryngologic Diseases