Risk Factors for Pediatric Difficult Supraglottic Airway Placement and Ventilation (PEDSGAP)

February 14, 2026 updated by: Alper Kilicaslan

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed 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

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
3750

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Turkey (Türkiye)
      • Ankara, Turkey (Türkiye)
        • Asli Dönmez
      • Istanbul, Turkey (Türkiye)
        • Emre Sertaç Bingül
      • Izmir, Turkey (Türkiye)
        • Gaye Aydin
      • Kayseri, Turkey (Türkiye)
        • Sibel Seckin Pehlivan
      • Konya, Turkey (Türkiye)
        • Necmettin Erbakan University
      • Trabzon, Turkey (Türkiye)
        • Sedat Saylan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
Immediately after the attempt of insertion and up to the end of the surgery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
At the beginning of anesthesia
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
Up to 24 hours after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Alper Kilicaslan

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Faruk Çiçekçi
Emre Sertaç Bingül
Nüzhet Mert Şentürk
Sibel Seçkin Pehlivan
Şengül Özmert
Özlem Sezen
Gaye Aydın
Esra Turunç
Sedat Saylan
Alkin Çolak

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Alper Kilicaslan, Necmettin Erbakan Universty Medical Faculty

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 9, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 30, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 26, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 5, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 10, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 17, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 14, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2023/4546

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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