Risk Factors for Pediatric Difficult Supraglottic Airway Placement and Ventilation

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.

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Key information

Conditions

Laryngeal Mask Airway Airway Management Children

Age range

1 year–12 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Asli Dönmez, Ankara, Turkey (Türkiye)

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

The incidence of difficulty in supraglottic airway device(SGA) placement

Time frame: Immediately after the attempt of insertion and up to the end of the surgery

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)

Secondary outcomes

Risk factors for pediatric difficult SGA placement

Time frame: At the beginning of anesthesia

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
The incidence of complications related to SGA insertion

Time frame: Up to 24 hours after surgery

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

Sponsors and collaborators

Lead sponsor

Alper Kilicaslan

Other

Collaborators

Alkin Çolak
Emre Sertaç Bingül
Esra Turunç
Faruk Çiçekçi
Gaye Aydın
Nüzhet Mert Şentürk
Sedat Saylan
Sibel Seçkin Pehlivan
Özlem Sezen
Şengül Özmert

Registry information

Official study title

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

Acronym: PEDSGAP

Important dates

Study start: 2023
Primary completion: 2024
Study completion: 2024
First posted: Oct 10, 2023
Registry last updated: Feb 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed