Risk Factors for Pediatric Difficult Supraglottic Airway Placement and Ventilation

NCT06073977 | Completed

• 1 other identifier: 2023/4546
• Study Type: observational
• Target: 3,750
• Locations: 1 country
• Sites: 6

Brief 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.

Conditions

Laryngeal Mask Airway; Children; Airway Management

Keywords

Supraglottic Airway; Laryngeal Mask Airway; Children; Complication

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Risk factors for pediatric difficult SGA placement

  At the beginning of anesthesia

• The incidence of complications related to SGA insertion

  Up to 24 hours after surgery

Eligibility Criteria

• Age: 1 Year - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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

You may qualify if:

• years old peditatric patients
• ASA class I- III
• Planned surgery under general anesthesia with supraglottic airway
• Patients whose legal guardians provide informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Alper Kilicaslan: lead
• Emre Sertaç Bingül: collaborator
• Nüzhet Mert Şentürk: collaborator
• Sibel Seçkin Pehlivan: collaborator
• Şengül Özmert: collaborator
• Özlem Sezen: collaborator
• Gaye Aydın: collaborator
• Esra Turunç: collaborator
• Faruk Çiçekçi: collaborator
• Sedat Saylan: collaborator
• Alkin Çolak: collaborator

Study Sites (6)

Asli Dönmez

Ankara, Turkey (Türkiye)

Location

Emre Sertaç Bingül

Istanbul, Turkey (Türkiye)

Location

Gaye Aydin

Izmir, Turkey (Türkiye)

Location

Sibel Seçkin Pehlivan

Kayseri, Turkey (Türkiye)

Location

Necmettin Erbakan University

Konya, Turkey (Türkiye)

Location

Sedat Saylan

Trabzon, Turkey (Türkiye)

Location

Study Officials

• Alper Kilicaslan

  Necmettin Erbakan Universty Medical Faculty

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof

Study Record Dates

• First Submitted: September 26, 2023
• First Posted: October 10, 2023
• Study Start: October 9, 2023
• Primary Completion: March 30, 2024
• Study Completion: April 1, 2024
• Last Updated: February 17, 2026

Record last verified: 2026-02

Locations

TU (6)