Utilization of Negative Pressure Suction to Reduce Aspiration in Oropharyngeal Dysphagia
Primary Purpose
Oropharyngeal Dysphagia
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Negative Pressure Suction Catheter
Sponsored by
About this trial
This is an interventional supportive care trial for Oropharyngeal Dysphagia focused on measuring Dysphagia, Oropharyngeal dysphagia, Video Fluoroscopic Swallowing Exam (VFSE)
Eligibility 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
Sites / Locations
- UC Davis Medical CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Negative Pressure Suction Device
Arm Description
Outcomes
Primary Outcome Measures
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.
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
Secondary Outcome Measures
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
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
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
Full Information
NCT ID
NCT03368079
First Posted
October 29, 2017
Last Updated
May 30, 2023
Sponsor
University of California, Davis
1. Study Identification
Unique Protocol Identification Number
NCT03368079
Brief Title
Utilization of Negative Pressure Suction to Reduce Aspiration in Oropharyngeal Dysphagia
Official Title
Utilization of Negative Pressure Suction to Reduce Aspiration in Oropharyngeal Dysphagia
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 30, 2016 (undefined)
Primary Completion Date
December 30, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Davis
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oropharyngeal Dysphagia
Keywords
Dysphagia, Oropharyngeal dysphagia, Video Fluoroscopic Swallowing Exam (VFSE)
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Negative Pressure Suction Device
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Negative Pressure Suction Catheter
Intervention Description
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 Measure Information:
Title
Degree of aspiration
Description
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.
Time Frame
During VFSE, from the beginning of administration of the first bolus size to completion of the VFSE
Title
Pharyngo-esophageal Segment (PES) opening size
Description
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
Time Frame
During VFSE, PES is measured when the patient administers 20 cc of liquid barium and the PES is maximally distended.
Secondary Outcome Measure Information:
Title
Pharyngeal Constriction Ratio (PCR)
Description
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
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.
Title
Oropharyngeal transit time
Description
Oropharyngeal transit time is measured when the patient administers 20 cc of liquid barium. Normal oropharyngeal transit time: 0.42 sec +/- 0.36 sec
Time Frame
Time from when bolus head first passes posterior nasal spine to time bolus head enters base of vallecula
Title
Hypopharyngeal transit time
Description
Hypopharyngeal transit time: is measured when the patient administers 20 cc of liquid barium. Normal Hypopharyngeal transit time: 0.77 sec +/- 0.26 sec
Time Frame
Time from when bolus head exits the vallecula to time when bolus tale exits PES
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Randev Sandhu, BS
Phone
916-734-2863
Email
rssandhu@ucdavis.edu
Facility Information:
Facility Name
UC Davis Medical Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Randev Sandhu, BS
Phone
916-734-2863
Email
rssandhu@ucdavis.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://studypages.com/s/a-study-of-negative-pressure-suction-to-reduce-aspiration-inhaling-food-into-lungs-oropharyngeal-dysphagia-swallowing-disorder-672909/
Description
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Utilization of Negative Pressure Suction to Reduce Aspiration in Oropharyngeal Dysphagia
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