Risk Factors for Pediatric Difficult Supraglottic Airway Placement and Ventilation

Children Clinical Trial

— PEDSGAP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06073977
• Other study ID #: 2023/4546
• Status: Recruiting
• Start date: October 9, 2023
• Est. completion date: April 1, 2024

Study information

• Verified date: March 2024
• Source: Konya Necmettin Erbakan Üniversitesi
• Contact: Alper Kilicaslan
• Phone: +905053780376
• Email: dralperkilicaslan[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3200
• Est. completion date: April 1, 2024
• Est. primary completion date: March 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Airway Management
• Children
• Laryngeal Mask Airway

Locations

Country	Name	City	State
Turkey	Alper KILICASLAN	Konya
Turkey	Necmettin Erbakan University	Konya

Sponsors (1)

Lead Sponsor	Collaborator
Konya Necmettin Erbakan Üniversitesi

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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