SafeLM Versus LMA Classic for Airway Management During Fibroadenoma Excision

NCT07835750 | Not Yet Recruiting FDA Device

• 1 other identifier: HMU-SAFELM-CLASSIC-2026-01
• Study Type: interventional
• Target: 132
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Airway Management

Keywords

Laryngeal Mask Airway; Video Laryngeal Mask; SafeLM; LMA Classic; Oropharyngeal Leak Pressure; Supraglottic Airway Device; General Anesthesia; Fibroadenoma Excision

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• First-attempt insertion success

  During initial laryngeal mask insertion

• Overall insertion success

  During laryngeal mask insertion, up to 3 attempts

• Laryngeal mask insertion time

  During laryngeal mask insertion

• Number of insertion attempts

  During laryngeal mask insertion

• Need for additional airway maneuvers

  During laryngeal mask insertion

Study Arms (2)

SafeLM Video Laryngeal Mask

EXPERIMENTAL

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

LMA Classic

ACTIVE COMPARATOR

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

Interventions

LMA Classic DEVICE

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.

LMA Classic

SafeLM Video Laryngeal Mask DEVICE

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.

SafeLM Video Laryngeal Mask

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hanoi Medical University: lead

Central Study Contacts

Hung T. Tran, MD

CONTACT

+84367378519; thanhhungvt@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will be unaware of the assigned laryngeal mask device. The anesthesiologist performing device insertion and intraoperative outcome assessment cannot be masked because of the visible differences between the two devices.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2026
• First Posted: September 23, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: September 23, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share