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Risk Factors for Pediatric Difficult Supraglottic Airway Placement and Ventilation

NCT ID: NCT06073977

Last Updated: 2025-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

3200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-10-09

Study Completion Date

2024-04-01

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 children 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

Conditions

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Laryngeal Mask Airway Children Airway Management

Keywords

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Supraglottic Airway Laryngeal Mask Airway Children Complication

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

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
Minimum Eligible Age

1 Year

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Emre Sertaç Bingül

UNKNOWN

Sponsor Role collaborator

Nüzhet Mert Şentürk

UNKNOWN

Sponsor Role collaborator

Sibel Seçkin Pehlivan

UNKNOWN

Sponsor Role collaborator

Şengül Özmert

UNKNOWN

Sponsor Role collaborator

Özlem Sezen

UNKNOWN

Sponsor Role collaborator

Gaye Aydın

UNKNOWN

Sponsor Role collaborator

Esra Turunç

UNKNOWN

Sponsor Role collaborator

Faruk Çiçekçi

UNKNOWN

Sponsor Role collaborator

Sedat Saylan

UNKNOWN

Sponsor Role collaborator

Alkin Çolak

UNKNOWN

Sponsor Role collaborator

Konya Necmettin Erbakan Üniversitesi

OTHER

Sponsor Role lead

Responsible Party

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Alper Kilicaslan

MD,Professor of Anesthesiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Alper Kilicaslan

Role: PRINCIPAL_INVESTIGATOR

Necmettin Erbakan Universty Medical Faculty

Locations

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Asli Dönmez

Ankara, , Turkey (Türkiye)

Site Status

Emre Sertaç Bingül

Istanbul, , Turkey (Türkiye)

Site Status

Gaye Aydin

Izmir, , Turkey (Türkiye)

Site Status

Sibel Seçkin Pehlivan

Kayseri, , Turkey (Türkiye)

Site Status

Necmettin Erbakan University

Konya, , Turkey (Türkiye)

Site Status

Sedat Saylan

Trabzon, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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2023/4546

Identifier Type: -

Identifier Source: org_study_id