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NOT YET RECRUITING
NCT07835750
NA

SafeLM Versus LMA Classic for Airway Management During Fibroadenoma Excision

Sponsor: Hanoi Medical University

View on ClinicalTrials.gov

Summary

This randomized controlled trial compares the airway management performance of the SafeLM video laryngeal mask with the LMA Classic in adult patients undergoing elective fibroadenoma excision under general anesthesia. Participants will be randomly assigned to airway management with either the SafeLM or the LMA Classic. The primary outcome is oropharyngeal leak pressure. Secondary outcomes include insertion performance, ventilation parameters, hemodynamic responses, and airway-related adverse events.

Official title: Comparison of Airway Control Effectiveness of the SafeLM Video Laryngeal Mask and the LMA Classic in Patients Undergoing General Anesthesia for Fibroadenoma Excision

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

132

Start Date

2026-10

Completion Date

2027-07

Last Updated

2026-10-07

Healthy Volunteers

No

Interventions

DEVICE

SafeLM Video Laryngeal Mask

The SafeLM is a video-assisted supraglottic airway device that allows visualization of the laryngeal structures during insertion and positioning. It will be used for airway management during general anesthesia according to the standardized study protocol.

DEVICE

LMA Classic

The LMA Classic is a conventional supraglottic airway device without video guidance. It will be used for airway management during general anesthesia according to the standardized study protocol.