SafeLM Versus LMA Classic for Airway Management During Fibroadenoma Excision

N/ANot Yet RecruitingNCT07835750

Hanoi Medical University132 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

OTHER

Masking

SINGLE

Enrollment

132

Conditions

Airway Management

Interventions

SafeLM Video Laryngeal MaskDEVICE

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.

LMA ClassicDEVICE

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.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: Immediately after successful laryngeal mask placement, before the start of surgery

Secondary Outcomes

First-attempt insertion success

Proportion of participants in whom effective ventilation is achieved after the first insertion attempt of the assigned laryngeal mask.

Time frame: 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.

Time frame: 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.

Time frame: During laryngeal mask insertion

Number of insertion attempts

Number of attempts required to achieve successful placement and effective ventilation with the assigned laryngeal mask.

Time frame: During laryngeal mask insertion

Need for additional airway maneuvers

Proportion of participants requiring additional maneuvers to achieve satisfactory placement and ventilation.

Time frame: During laryngeal mask insertion

Central Contacts

Hung T. Tran, MD

CONTACT

+84367378519 thanhhungvt@gmail.com

Data from ClinicalTrials.gov

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