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NOT YET RECRUITING
NCT07912619
NA

Comparison of Second- and Third-Generation Laryngeal Mask Airway in Pediatric Patients

Sponsor: Bursa Yuksek Ihtisas Training and Research Hospital

View on ClinicalTrials.gov

Summary

This study compares two airway devices used during general anesthesia in children: a second-generation laryngeal mask (SafeLM LMA) and a third-generation video laryngeal mask (SafeLM Video LMA). Both devices are CE-marked and routinely used in clinical practice. The study will include 90 children aged 2 to 8 years who are scheduled for elective surgery. Children will be randomly assigned to one of two groups (45 per group), and one of the two devices will be placed after anesthesia induction. The main outcome is oropharyngeal leak pressure, which shows how well the mask seals the airway. Other outcomes include success at the first insertion attempt, number of attempts, view of the vocal cords (video group), heart rate and blood pressure changes, and complications such as laryngospasm, low oxygen levels, sore throat, hoarseness, and nausea/vomiting. The study aims to show whether video-guided placement improves airway seal and safety in children.

Official title: Effects of Second-Generation Laryngeal Mask Airway Versus Third-Generation Video Laryngeal Mask Airway on Airway Management in Pediatric Patients

Key Details

Gender

All

Age Range

2 Years - 8 Years

Study Type

INTERVENTIONAL

Enrollment

90

Start Date

2026-11-01

Completion Date

2027-02-01

Last Updated

2026-11-03

Healthy Volunteers

No

Interventions

DEVICE

Second-Generation SafeLM LMA

A second-generation supraglottic airway device (SafeLM LMA) inserted after standard anesthesia induction to secure the airway. This device does not include a camera or video guidance component.

DEVICE

Third-Generation SafeLM Video LMA

A third-generation video-guided supraglottic airway device (SafeLM Video LMA) inserted after standard anesthesia induction. The integrated adjustable camera provides real-time visualization to guide correct placement.

Locations (1)

SBÜ Bursa Yüksek İhtisas Eğitim ve Araştırma Hastanesi

Bursa, Turkey (Türkiye)