Utilization of Negative Pressure Suction to Reduce Aspiration in Oropharyngeal Dysphagia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1
- 试验地点
- 2
- 主要终点
- Pharyngo-esophageal Segment (PES) opening size
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
Negative Pressure Suction Device
干预措施: Negative Pressure Suction Catheter (Device)
结局指标
主要结局
Pharyngo-esophageal Segment (PES) opening size
时间窗: 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
Degree of aspiration
时间窗: 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.
次要结局
- Pharyngeal Constriction Ratio (PCR)(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 from when bolus head first passes posterior nasal spine to time bolus head enters base of vallecula)
- Hypopharyngeal transit time(Time from when bolus head exits the vallecula to time when bolus tale exits PES)