Zhejiang Cancer Hospital has initiated a groundbreaking clinical investigation comparing the performance and effectiveness of three supraglottic airway devices—GMA-Tulip, I-gel, and LMA Supreme. This in vivo CT imaging study, now actively recruiting, aims to provide valuable data for clinical and regulatory decision-making processes in airway management.
Published: September 29, 2025
What is the study about?
The study titled “An in Vivo CT Imaging Study of GMA-Tulip, I-gel, and LMA Supreme” is focused on evaluating the performance of three widely used supraglottic airway devices. GMA-Tulip, I-gel, and LMA Supreme are being analyzed under clinical conditions to optimize airway management strategies, particularly for patients requiring intensive respiratory support.
Supraglottic airway devices are essential in scenarios where endotracheal intubation may be contraindicated or challenging. By leveraging comparative data obtained through CT imaging, researchers aim to offer detailed insights into device effectiveness, anatomical fit, and safety profiles.
How is the study conducted?
Device Interventions
Participants in this study will undergo the insertion of one of the following devices: GMA-Tulip, I-gel, or LMA Supreme. These devices will then be assessed using CT imaging to capture precise morphological and functional data during use.
Clinical Applications
CT imaging will enable high-resolution observation of the supraglottic airway structure and potential interactions with the devices. Researchers will prioritize clinical metrics such as airflow efficiency, device positioning, and mucosal safety.
Recruitment
Active recruitment is underway at Zhejiang Cancer Hospital. This ensures a robust pool of participants to generate statistically significant and clinically relevant findings.
Why does this matter?
This study is expected to provide actionable insights for clinicians and regulators alike. By understanding device-specific advantages and limitations, healthcare professionals can make informed choices tailored to patient-specific needs. Furthermore, the findings may influence current regulatory guidelines for supraglottic airway devices, addressing design enhancements or safety criteria.
The clinical trial also supports manufacturers by delivering evidence-based feedback, which could lead to innovations in the next generation of airway management technologies.
FAQs
- What is the primary focus of the study?
The study aims to evaluate the performance and safety of three supraglottic airway devices. - Who can participate in the study?
Recruitment is active at Zhejiang Cancer Hospital, and eligibility details are available through the sponsor. - How are the results useful?
The data will support clinical decision-making and may impact regulatory considerations for airway devices.
Conclusion
The ongoing clinical trial highlights the importance of data-driven approaches in the evaluation of supraglottic airway devices. Regulatory and clinical teams should closely monitor developments from this study to understand emerging trends and implications for device approval pathways.
Disclaimer
This content is prepared for informational purposes and should not be considered legal, regulatory, or clinical advice.
Announcement
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07196696?term=medical+device