Utilization of Negative Pressure Suction to Reduce Aspiration in Oropharyngeal Dysphagia
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|ClinicalTrials.gov Identifier: NCT03368079|
Recruitment Status : Recruiting
First Posted : December 11, 2017
Last Update Posted : June 13, 2019
|Condition or disease||Intervention/treatment||Phase|
|Oropharyngeal Dysphagia||Device: Negative Pressure Suction Catheter||Not Applicable|
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 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|
|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.
- 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:
- 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 [ 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
- 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
- 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
- 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
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
|Contact: Ahmed Bayoumi, MB BChfirstname.lastname@example.org|
|United States, California|
|UC Davis Medical Center||Recruiting|
|Sacramento, California, United States, 95817|
|Contact: Ahmed Bayoumi, MB BCh 916-734-2863 email@example.com|