Observational Imaging Study on Real-Time Dynamic Changes of Normal Pharyngolaryngeal Structures During Barium Swallow in Patients Undergoing Routine Barium Meal Examination
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Real-time dynamic changes of pharyngolaryngeal structures during swallowing
研究概览
简要总结
The integrity and functional stability of pharyngolaryngeal anatomical structures are critical for airway management, and the dynamic changes of key structures (e.g., pyriform sinus, cricoid cartilage lamina) during swallowing directly relate to the design and clinical safety of laryngeal masks. This observational study aims to investigate the real-time dynamic changes and physiological movement patterns of normal pharyngolaryngeal structures during barium swallow using routine barium meal examination imaging. The findings will provide anatomical and physiological evidence for optimizing laryngeal mask design and improving its anatomical fit with the pharynx and larynx.
详细描述
After approval by the Ethics Committee of Zhejiang Cancer Hospital (Approval Number: IRB-2025-1096(IIT)), this study will be registered on ClinicalTrials.gov prior to participant enrollment. Given that the study only utilizes de-identified imaging data from routine barium meal examinations (no additional procedures or interventions for participants), informed consent is exempted as approved by the Ethics Committee. The study is planned to be conducted from August 2025 to October 2025.
Eligible participants are patients undergoing routine barium meal examinations at Zhejiang Cancer Hospital, meeting the inclusion criteria (18-75 years old, no pharyngolaryngeal surgery/trauma/congenital malformation, no swallowing dysfunction, unobstructed oropharyngeal-esophageal pathway, etc.) and excluding those with contraindications (e.g., goiter compressing pharyngolaryngeal structures, barium allergy).
Barium Swallow Examination Procedure:
All procedures follow the standard clinical protocol for barium meal examinations, with no additional radiation exposure or burden on participants:
Static Imaging (Resting State): Participants assume a standing position. A digital X-ray machine (Shimadzu Uni-vision) is used to obtain static images of the pharyngolaryngeal region, recording the baseline anatomical positions of the pyriform sinus, cricoid cartilage lamina, and esophageal inlet.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18-75 years;
- •No history of pharyngolaryngeal surgery, trauma, or congenital malformation;
- •No swallowing dysfunction, pharyngolaryngeal inflammation, or neurological diseases affecting swallowing;
- •No recent use of drugs that affect muscle function (e.g., muscle relaxants, anticholinergics);
- •Barium meal examination confirms unobstructed oropharyngeal-esophageal pathway;
- •Normal pharyngolaryngeal anatomical structure (confirmed by preliminary imaging review);
- •Scheduled to undergo routine barium meal examination at Zhejiang Cancer Hospital for clinical diagnosis.
排除标准
- •Presence of diseases that may compress pharyngolaryngeal structures (e.g., goiter, mediastinal mass);
- •Allergy to barium sulfate or other components of the barium suspension.
结局指标
主要结局
Real-time dynamic changes of pharyngolaryngeal structures during swallowing
时间窗: From the initiation of the barium swallow to the complete passage of the bolus through the upper esophageal sphincter, as assessed under videofluoroscopy (an average of 15 minutes per participant).
Measurement of displacement distance of the cricoid cartilage lamina, expansion amplitude of the pyriform sinus, and movement trajectory of the esophageal inlet during swallowing (assessed via dynamic fluoroscopic imaging).
次要结局
- Proportion of participants with consistent instrument insertion pathway and barium's preferred pathway (pyriform sinus)(From the initiation of the barium swallow to the complete passage of the bolus through the upper esophageal sphincter, as assessed under videofluoroscopy (an average of 15 minutes per participant).)
研究者
Wang Jiangling
Principal Investigator
Zhejiang Cancer Hospital