About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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);
Disqualifiers
Presence of diseases that may compress pharyngolaryngeal structures (e.g., goiter, mediastinal mass);
Allergy to barium sulfate or other components of the barium suspension.
Trial population
Patient scheduled to take barium meal examination
Trial design
Cohort
Other
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Real-time dynamic changes of pharyngolaryngeal structures during swallowing
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).
Secondary outcomes
Proportion of participants with consistent instrument insertion pathway and barium's preferred pathway (pyriform sinus)
Analysis of the consistency between the barium's preferred pathway (pyriform sinus) and the insertion pathway of laryngeal mask-related instruments, to explain the anatomical fit differences among three laryngeal mask designs (LMA Supreme, I-gel, GMA-Tulip).
Other outcomes
Barium flow speed through the oropharynx
The speed of barium flow through the oropharyngeal region, measured by videofluoroscopic swallowing study. The speed will be calculated by tracking the movement of the barium bolus head between two predefined anatomical points (e.g., the pyriform sinus and the lower edge of the cricoid cartilage) and reported in millimeters per second (mm/s)
Preferred pathway of barium flow
The primary anatomical pathway of the barium bolus as it passes the laryngeal inlet, assessed by videofluoroscopy. The pathway will be categorized as either passing through the pyriform sinuses or through other channels (e.g., directly over the arytenoids). The result will be reported as the proportion (percentage) of participants with barium flow primarily through the pyriform sinuses.
Displacement of the cricoid cartilage lamina during barium swallow
The extent of posterior-inferior displacement of the cricoid cartilage lamina during the pharyngeal phase of swallowing, measured on lateral videofluoroscopic images. The displacement will be quantified as the vertical distance (in millimeters) from the resting position of the cricoid cartilage to its maximum displaced position.
Sponsors and contacts
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