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

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

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.

Study Overview

• Status: Completed
• Conditions: Children; Airway Management; Laryngeal Mask Airway

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

• Study Type: Observational
• Enrollment (Actual): 3750

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Ankara, Turkey (Türkiye)
    • Asli Dönmez
  • Istanbul, Turkey (Türkiye)
    • Emre Sertaç Bingül
  • Izmir, Turkey (Türkiye)
    • Gaye Aydin
  • Kayseri, Turkey (Türkiye)
    • Sibel Seckin Pehlivan
  • Konya, Turkey (Türkiye)
    • Necmettin Erbakan University
  • Trabzon, Turkey (Türkiye)
    • Sedat Saylan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

1- 12 years old peditatric patients scheduled for elective surgery under general anaesthesia, in whom a SGA would be used for airway maintenance

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The incidence of difficulty in supraglottic airway device(SGA) placement	Difficulty in placing SGA is defined as follows: SGA insertion that requires more than one attempt,need for a change the size or type of SGA,desatutaion (SpO2<93%), disrupted capnography,high airway pressure (>25 cmH2O of peak pressure)	Immediately after the attempt of insertion and up to the end of the surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Risk factors for pediatric difficult SGA placement	Possible risk factors related with failure and difficulty listed as:experience of the anaesthetist , presence of history of asthma/pneumoniae,presence of craniofascial anomalies, use of neuromuscular blocking agent, type and placement technique of SGA	At the beginning of anesthesia
The incidence of complications related to SGA insertion	The incidence of adverse events including laryngospasm, desaturation bronchospasm, stridor, regurgitation bucking, airway trauma and postoperative complications including difficult weaning, cough, stridor, vomiting, dysfagia, dysphonia	Up to 24 hours after surgery

Collaborators and Investigators

• Sponsor: Alper Kilicaslan
• Collaborators: Faruk Çiçekçi; Emre Sertaç Bingül; Nüzhet Mert Şentürk; Sibel Seçkin Pehlivan; Şengül Özmert; Özlem Sezen; Gaye Aydın; Esra Turunç; Sedat Saylan; Alkin Çolak
• Investigators: Principal Investigator: Alper Kilicaslan, Necmettin Erbakan Universty Medical Faculty

Study record dates

Study Major Dates

• Study Start (Actual): October 9, 2023
• Primary Completion (Actual): March 30, 2024
• Study Completion (Actual): April 1, 2024

Study Registration Dates

• First Submitted: September 26, 2023
• First Submitted That Met QC Criteria: October 5, 2023
• First Posted (Actual): October 10, 2023

Study Record Updates

• Last Update Posted (Actual): February 17, 2026
• Last Update Submitted That Met QC Criteria: February 14, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Children; Complication; Laryngeal Mask Airway; Supraglottic Airway
• Other Study ID Numbers: 2023/4546

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No