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SafeLM Versus LMA Classic for Airway Management During Fibroadenoma Excision

2 oktober 2026 uppdaterad av: Hanoi Medical University

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.

Studieöversikt

Status

Har inte rekryterat ännu

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Beräknad)

132

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Kvinna

Beskrivning

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Övrig
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Enda

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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.
Enhet: 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.
Aktiv 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.
Enhet: 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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Oropharyngeal Leak Pressure (OLP)
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
First-attempt insertion success
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: During laryngeal mask insertion

Proportion of participants requiring additional maneuvers to achieve satisfactory placement and ventilation.
During laryngeal mask insertion
Peak inspiratory pressure
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: Immediately after device removal

Presence of visible blood staining on the laryngeal mask after removal.
Immediately after device removal
Postoperative sore throat
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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

Samarbetspartners och utredare

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Sponsor

Hanoi Medical University

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

1 oktober 2026

Primärt slutförande (Beräknad)

1 juni 2027

Avslutad studie (Beräknad)

1 juli 2027

Studieregistreringsdatum

Först inskickad

16 september 2026

Först inskickad som uppfyllde QC-kriterierna

16 september 2026

Första postat (Faktisk)

23 september 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

7 oktober 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

2 oktober 2026

Senast verifierad

1 september 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Andra studie-ID-nummer

  • HMU-SAFELM-CLASSIC-2026-01

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