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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Hung T. Tran, MD
- Número de teléfono: +84367378519
- Correo electrónico: thanhhungvt@gmail.com
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
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. |
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. |
|
Comparador activo: 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. |
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. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Oropharyngeal Leak Pressure (OLP)
Periodo de tiempo: Immediately after successful laryngeal mask placement, before the start of surgery
|
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
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
First-attempt insertion success
Periodo de tiempo: During initial laryngeal mask insertion
|
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
Periodo de tiempo: During laryngeal mask insertion, up to 3 attempts
|
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
Periodo de tiempo: During laryngeal mask insertion
|
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
Periodo de tiempo: During laryngeal mask insertion
|
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
Periodo de tiempo: During laryngeal mask insertion
|
Proportion of participants requiring additional maneuvers to achieve satisfactory placement and ventilation. |
During laryngeal mask insertion
|
|
Peak inspiratory pressure
Periodo de tiempo: At 5 and 30 minutes after successful laryngeal mask placement
|
Peak inspiratory airway pressure measured in cmH2O during mechanical ventilation. |
At 5 and 30 minutes after successful laryngeal mask placement
|
|
End-tidal carbon dioxide
Periodo de tiempo: At 5 and 30 minutes after successful laryngeal mask placement
|
End-tidal carbon dioxide (EtCO2) measured during mechanical ventilation. |
At 5 and 30 minutes after successful laryngeal mask placement
|
|
Heart Rate
Periodo de tiempo: At baseline, immediately after successful laryngeal mask placement, and at 5 and 30 minutes after placement
|
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
Periodo de tiempo: Immediately after device removal
|
Presence of visible blood staining on the laryngeal mask after removal. |
Immediately after device removal
|
|
Postoperative sore throat
Periodo de tiempo: At 1 and 24 hours after surgery
|
Presence of patient-reported sore throat following general anesthesia. |
At 1 and 24 hours after surgery
|
|
Postoperative hoarseness
Periodo de tiempo: At 1 and 24 hours after surgery
|
Presence of patient-reported hoarseness following general anesthesia. |
At 1 and 24 hours after surgery
|
|
Airway-related adverse events
Periodo de tiempo: From laryngeal mask insertion through postoperative observation, assessed up to 24 hours after surgery
|
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
Periodo de tiempo: At baseline, immediately after successful laryngeal mask placement, and at 5 and 30 minutes after placement
|
Arterial pressure will be recorded in mmHg. |
At baseline, immediately after successful laryngeal mask placement, and at 5 and 30 minutes after placement
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- HMU-SAFELM-CLASSIC-2026-01
Plan de datos de participantes individuales (IPD)
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Información sobre medicamentos y dispositivos, documentos del estudio
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