Airway Management
Conditions
Keywords
Laryngeal Mask Airway, Video Laryngeal Mask, SafeLM, LMA Classic, Oropharyngeal Leak Pressure, Supraglottic Airway Device, General Anesthesia, Fibroadenoma Excision
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.
Detailed description
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.
Interventions
DEVICESafeLM 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.
DEVICELMA 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.
Sponsors
Hanoi Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)
Masking description
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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Oropharyngeal Leak Pressure (OLP) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| First-attempt insertion success | During initial laryngeal mask insertion | Proportion of participants in whom effective ventilation is achieved after the first insertion attempt of the assigned laryngeal mask. |
| Overall insertion success | 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. |
| Laryngeal mask insertion time | During laryngeal mask insertion | Time in seconds from introduction of the assigned laryngeal mask into the mouth until establishment of effective ventilation. |
| Number of insertion attempts | During laryngeal mask insertion | Number of attempts required to achieve successful placement and effective ventilation with the assigned laryngeal mask. |
| Need for additional airway maneuvers | During laryngeal mask insertion | Proportion of participants requiring additional maneuvers to achieve satisfactory placement and ventilation. |
| Peak inspiratory pressure | At 5 and 30 minutes after successful laryngeal mask placement | Peak inspiratory airway pressure measured in cmH2O during mechanical ventilation. |
| End-tidal carbon dioxide | At 5 and 30 minutes after successful laryngeal mask placement | End-tidal carbon dioxide (EtCO2) measured during mechanical ventilation. |
| Heart Rate | 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). |
| Blood staining on the laryngeal mask | Immediately after device removal | Presence of visible blood staining on the laryngeal mask after removal. |
| Postoperative sore throat | At 1 and 24 hours after surgery | Presence of patient-reported sore throat following general anesthesia. |
| Postoperative hoarseness | At 1 and 24 hours after surgery | Presence of patient-reported hoarseness following general anesthesia. |
| Airway-related adverse events | 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. |
| Arterial Pressure | At baseline, immediately after successful laryngeal mask placement, and at 5 and 30 minutes after placement | Arterial pressure will be recorded in mmHg. |
Contacts
CONTACTHung T. Tran, MD
Outcome results
None listed