Risk Factors for Pediatric Difficult Supraglottic Airway Placement and Ventilation

Study Overview
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Brief Summary
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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 infants and clarify the possible risk factors for difficulty.

Detailed Description
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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

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

Conditions
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Laryngeal Mask Airway, Children, Airway Management

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Supraglottic Airway, Laryngeal Mask Airway, Children, Complication