NCT06073977

Risk Factors for Pediatric Difficult Supraglottic Airway Placement and Ventilation

Risk Factors for Pediatric Difficult Supraglottic Airway Placement and Ventilation (PEDSGAP): A Multicentric Prospective Observational Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 3,750 (actual)
• Sponsor: Alper Kilicaslan · Academic / Other
• Sex: All
• Age: 1 Year – 12 Years
• Healthy volunteers: Not accepted

Summary

This study is designed to observe the occurrence of failure or difficulty during placement of supraglottic airway devices (SGAs) and its associated risk factors in pediatric patients. Despite wide use in pediatric practice, not much is known related to problems during SGA insertion unlike adults. The main information regarding pediatric SGA comes from either small comparative studies or retrospective studies reporting increased risk of failure. Thus the main aim of this prospective, multicentric, observational study is to determine the incidence of "difficult" or "failed" SGA placement in children and clarify the possible risk factors for difficulty.

Detailed description

Inclusion criteria * 1- 12 years old peditatric patients * ASA class I- III * Scheduled for elective surgery under general anaesthesia, in whom a SGA would be used for airway maintenance * Planned surgery under general anesthesia with SGA * Patients whose legal guardians provide informed consent Exclusion criteria * Refusal to participate in the study. * Inability of patient or parents to understand the study or consent process * Orotracheal intubation requirement * Pathology of airway, neck, respiratory tract, upper gastrointestinal tract * Increased risk of regurgitation or aspiration * Emergency surgeries * Requirement for intensive care follow-up after the surgery

Conditions

• Laryngeal Mask Airway
• Children
• Airway Management

Timeline

• Start date: 2023-10-09
• Primary completion: 2024-03-30
• Completion: 2024-04-01
• First posted: 2023-10-10
• Last updated: 2026-02-17

Locations

6 sites across 1 country: Turkey (Türkiye)