High Resolution Manometry: Optimizing the Swallow Protocol
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 71
- 试验地点
- 1
- 主要终点
- Normal values for HRM while the patient is in the most physiologic position to stimulate normal eating habits.
研究概览
简要总结
This study is using a new technology known as high resolution manometry which is used to evaluate patients that have trouble swallowing or have chest pain that is not related to the heart. The investigator wants to learn how the different positions of the body, in a lying position, semi-recumbent, sitting position or standing up, and the amount of liquid affects the outcome of the test. This will help the investigator to determine a standardized protocol for patients with trouble swallowing.
详细描述
The esophageal manometry will be performed in the motility lab at the Shands Endoscopy Center by passing a small tube into the patients nose, down the food pipe and into the stomach. The participants will be instructed to swallow a determined volume of Gatorade,depending on the protocol being followed. All participants will be starting in the supine position followed by semi-recumbent,sitting, then standing up. When the esophageal manometry is finished, the tube is removed and participation in this study is complete.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18-80
- •Healthy Volunteer
- •No clinical evidence of dysphagia
排除标准
- •History of prior dysphagia
- •Prior esophageal or gastric dysmotility secondary to systemic conditions (scleroderma or diabetes mellitus)
- •Known gastrointestinal malignancy
- •Use of medications known to affect esophageal or gastric motility (e.g. anticholinergics, opiates, calcium channel blockers)
- •Previous esophageal or gastric surgery
- •Significant cardiac or respiratory disease
- •Pregnancy (a pregnancy test will be performed in women of child-bearing potential)
研究组 & 干预措施
esophageal manometry
Esophageal manometry will be performed by swallowing different amounts of Gatorade depending on the protocol being followed. There will be alternate assignment of positions: supine position, semi-recumbent position,sitting position and standing up position.
干预措施: esophageal manometry (Procedure)
esophageal manometry
Esophageal manometry will be performed by swallowing different amounts of Gatorade depending on the protocol being followed. There will be alternate assignment of positions: supine position, semi-recumbent position,sitting position and standing up position.
干预措施: Gatorade (Dietary Supplement)
esophageal manometry
Esophageal manometry will be performed by swallowing different amounts of Gatorade depending on the protocol being followed. There will be alternate assignment of positions: supine position, semi-recumbent position,sitting position and standing up position.
干预措施: Supine position (Other)
esophageal manometry
Esophageal manometry will be performed by swallowing different amounts of Gatorade depending on the protocol being followed. There will be alternate assignment of positions: supine position, semi-recumbent position,sitting position and standing up position.
干预措施: Semi-recumbent position (Other)
esophageal manometry
Esophageal manometry will be performed by swallowing different amounts of Gatorade depending on the protocol being followed. There will be alternate assignment of positions: supine position, semi-recumbent position,sitting position and standing up position.
干预措施: Sitting (Procedure)
esophageal manometry
Esophageal manometry will be performed by swallowing different amounts of Gatorade depending on the protocol being followed. There will be alternate assignment of positions: supine position, semi-recumbent position,sitting position and standing up position.
干预措施: Standing (Procedure)
结局指标
主要结局
Normal values for HRM while the patient is in the most physiologic position to stimulate normal eating habits.
时间窗: up to 1 hour
The patient is instructed to swallow a determined volume of Gatorade. All participants will be starting in the supine position followed by semi-recumbent,sitting, then standing up.
次要结局
- Normal HRM values for a 200 ml provocative swallow.(up to 5 minutes)
- Normal size and diameter of esophagus and esophageal distension on a regular basis with the provocative swallow and impedance.(up to 1 hour)
- Standardization of the testing protocol for HRM and the reliability of volume and number of swallows.(up to 1 hour)
- Bolus clearance for each swallow with impedance.(up to 1 hour)