SafeLM Versus LMA Classic for Airway Management During Fibroadenoma Excision

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Airway Management
• Intervention / Treatment: Device: SafeLM Video Laryngeal Mask; Device: LMA Classic

Detailed Description

The SafeLM is a video-assisted laryngeal mask that allows visualization during placement, whereas the LMA Classic is a conventional supraglottic airway device. This study is designed to compare the clinical performance of these two devices under standardized conditions.

Adult patients scheduled for elective fibroadenoma excision under general anesthesia will be screened for eligibility. Only patients for whom both devices are considered clinically appropriate will be enrolled, thereby avoiding randomization when patient characteristics indicate a preference for a particular airway management technique. Eligible participants will be randomly assigned to airway management with either the SafeLM or the LMA Classic.

After standardized induction of general anesthesia, the assigned laryngeal mask will be inserted according to the study protocol. The primary outcome is oropharyngeal leak pressure after successful placement. Device insertion characteristics, ventilation parameters, hemodynamic responses, and airway-related adverse events will also be evaluated.

• Study Type: Interventional
• Enrollment (Estimated): 132
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hung T. Tran, MD; Phone Number: +84367378519; Email: thanhhungvt@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Female patients aged 18 years or older.
• Scheduled for elective excision of benign breast fibroadenoma under general anesthesia.
• Planned airway management with a laryngeal mask airway.
• American Society of Anesthesiologists (ASA) physical status I-II.
• Both the SafeLM and LMA Classic are considered clinically appropriate for airway management.
• Provision of written informed consent.

Exclusion Criteria:

• Increased risk of pulmonary aspiration, including inadequate preoperative fasting, full stomach, or gastrointestinal obstruction.
• Known or suspected difficult airway or other airway characteristics for which random allocation between the two study devices is considered clinically inappropriate.
• Upper airway pathology or anatomical abnormality that may interfere with laryngeal mask placement.
• Clinical or surgical indication requiring tracheal intubation rather than a laryngeal mask airway.
• Contraindication or known allergy to medications used in the standardized anesthesia protocol.
• Inability to provide informed consent.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SafeLM Video Laryngeal Mask; Participants randomized to this arm will receive airway management with the SafeLM video laryngeal mask during general anesthesia for elective fibroadenoma excision. The device will be inserted according to the standardized study protocol.	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.
Active Comparator: LMA Classic; Participants randomized to this arm will receive airway management with the LMA Classic during general anesthesia for elective fibroadenoma excision. The device will be inserted 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oropharyngeal Leak Pressure (OLP)	Oropharyngeal leak pressure will be measured after successful placement of the assigned laryngeal mask and establishment of effective ventilation. OLP will be recorded in cmH2O as the airway pressure at which an audible oropharyngeal leak is detected during a standardized leak test.	Immediately after successful laryngeal mask placement, before the start of surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
First-attempt insertion success	Proportion of participants in whom effective ventilation is achieved after the first insertion attempt of the assigned laryngeal mask.	During initial laryngeal mask insertion
Overall insertion success	Proportion of participants in whom effective ventilation is achieved with the assigned laryngeal mask within the maximum number of insertion attempts permitted by the study protocol.	During laryngeal mask insertion, up to 3 attempts
Laryngeal mask insertion time	Time in seconds from introduction of the assigned laryngeal mask into the mouth until establishment of effective ventilation.	During laryngeal mask insertion
Number of insertion attempts	Number of attempts required to achieve successful placement and effective ventilation with the assigned laryngeal mask.	During laryngeal mask insertion
Need for additional airway maneuvers	Proportion of participants requiring additional maneuvers to achieve satisfactory placement and ventilation.	During laryngeal mask insertion
Peak inspiratory pressure	Peak inspiratory airway pressure measured in cmH2O during mechanical ventilation.	At 5 and 30 minutes after successful laryngeal mask placement
End-tidal carbon dioxide	End-tidal carbon dioxide (EtCO2) measured during mechanical ventilation.	At 5 and 30 minutes after successful laryngeal mask placement
Heart Rate	Heart rate will be recorded in beats per minute (bpm).	At baseline, immediately after successful laryngeal mask placement, and at 5 and 30 minutes after placement
Blood staining on the laryngeal mask	Presence of visible blood staining on the laryngeal mask after removal.	Immediately after device removal
Postoperative sore throat	Presence of patient-reported sore throat following general anesthesia.	At 1 and 24 hours after surgery
Postoperative hoarseness	Presence of patient-reported hoarseness following general anesthesia.	At 1 and 24 hours after surgery
Airway-related adverse events	Occurrence of airway-related adverse events, including laryngospasm and clinically evident regurgitation.	From laryngeal mask insertion through postoperative observation, assessed up to 24 hours after surgery
Arterial Pressure	Arterial pressure will be recorded in mmHg.	At baseline, immediately after successful laryngeal mask placement, and at 5 and 30 minutes after placement

Collaborators and Investigators

• Sponsor: Hanoi Medical University

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): July 1, 2027

Study Registration Dates

• First Submitted: September 16, 2026
• First Submitted That Met QC Criteria: September 16, 2026
• First Posted (Actual): September 23, 2026

Study Record Updates

• Last Update Posted (Actual): October 7, 2026
• Last Update Submitted That Met QC Criteria: October 2, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Keywords: General Anesthesia; Laryngeal Mask Airway; Video Laryngeal Mask; Supraglottic Airway Device; Oropharyngeal Leak Pressure; SafeLM; LMA Classic; Fibroadenoma Excision
• Other Study ID Numbers: HMU-SAFELM-CLASSIC-2026-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No