Real-Time Dynamic Imaging Study of Normal Pharyngolaryngeal Structures During Barium Swallow (GLAM-III)

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorZhejiang Cancer Hospital

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

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).

Time frame
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).

Secondary outcomes

1

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).

Time frame
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).

Other outcomes

1

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)

Time frame
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).
2

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.

Time frame
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).
3

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.

Time frame
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).

Sponsors and contacts

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