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.
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Szczegółowy opis
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.
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Hung T. Tran, MD
- Numer telefonu: +84367378519
- E-mail: thanhhungvt@gmail.com
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
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 studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Inny
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Pojedynczy
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Eksperymentalny: 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. |
|
Aktywny komparator: 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. |
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Oropharyngeal Leak Pressure (OLP)
Ramy czasowe: 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
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
First-attempt insertion success
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: During laryngeal mask insertion
|
Proportion of participants requiring additional maneuvers to achieve satisfactory placement and ventilation. |
During laryngeal mask insertion
|
|
Peak inspiratory pressure
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: Immediately after device removal
|
Presence of visible blood staining on the laryngeal mask after removal. |
Immediately after device removal
|
|
Postoperative sore throat
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
|
Współpracownicy i badacze
Sponsor
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Inne numery identyfikacyjne badania
- HMU-SAFELM-CLASSIC-2026-01
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
produkt wyprodukowany i wyeksportowany z USA
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