Risk Factors for Pediatric Difficult Supraglottic Airway Placement and Ventilation (PEDSGAP)

Alper Kilicaslan

Status: Completed

Conditions: Laryngeal Mask Airway; Airway Management; Children

Study type: Observational

Funder types: Other

Identifiers

NCT06073977

2023/4546

Details and patient eligibility

About

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.

Full 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

Enrollment: 3,200 patients

Sex: All

Ages: 1 to 12 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 1- 12 years old peditatric patients
• ASA class I- III
• Planned surgery under general anesthesia with supraglottic airway
• 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