Laryngeal Mask AirwayPEDSGAPNCT06073977
Risk Factors for Pediatric Difficult Supraglottic Airway Placement and Ventilation
An observational study of Laryngeal Mask Airway and Children, run by Alper Kilicaslan at 6 sites in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 1 year to 12 years
- Conditions the study is for
- Laryngeal Mask Airway, Children, Airway Management
- How many people
- 3,750 participants
- Where
- 6 sitesTurkey (Türkiye)
- Study dates
- 9 Oct 2023to 1 Apr 2024
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 12 years
- All sexes
- No healthy volunteers
- Child
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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Turkey (Türkiye)6 sites
Asli Dönmez
Ankara
Emre Sertaç Bingül
Istanbul
Gaye Aydin
Izmir
Sibel Seçkin Pehlivan
Kayseri
Necmettin Erbakan University
Konya
Sedat Saylan
Trabzon
About this study
Official title: 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.
Read the 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
- Conditions
- Laryngeal Mask Airway, Children, Airway Management
- Keywords
- Supraglottic Airway, Laryngeal Mask Airway, Children, Complication
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Immediately after the attempt of insertion and up to the end of the surgery
Secondary outcomes (2)
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
Measured: 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
Measured: Up to 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2023
- Study start9 Oct 2023
- Primary completion30 Mar 2024
- Study completion1 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laryngeal Mask AirwayStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,750 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Alper Kilicaslan
- Sponsor type
- University, hospital or other
- Collaborators
- Emre Sertaç Bingül, Nüzhet Mert Şentürk, Sibel Seçkin Pehlivan, Şengül Özmert, Özlem Sezen, Gaye Aydın, Esra Turunç, Faruk Çiçekçi, Sedat Saylan, Alkin Çolak
- Responsible party
- Sponsor-investigator, Alper Kilicaslan, Konya Necmettin Erbakan Üniversitesi
- Investigators
- Alper Kilicaslan, Principal investigator, Necmettin Erbakan Universty Medical Faculty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06073977
- Sponsor's protocol ID
- 2023/4546
- Acronym
- PEDSGAP
- Status last verified
- Feb 2026
- First submitted
- 26 Sep 2023
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors for Pediatric Difficult Supraglottic Airway Placement and Ventilation (PEDSGAP): A Multicentric Prospective Observational Study
- ClinicalTrials.gov ID
- NCT06073977
- Acronym / sponsor ID
- PEDSGAP / 2023/4546
- Conditions
- Laryngeal Mask Airway, Children, Airway Management
- Keywords
- Supraglottic Airway, Laryngeal Mask Airway, Children, Complication
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,750 participants (actual)
- Lead sponsor
- Alper KilicaslanUniversity, hospital or other
- Collaborators
- Emre Sertaç Bingül, Nüzhet Mert Şentürk, Sibel Seçkin Pehlivan, Şengül Özmert, Özlem Sezen, Gaye Aydın, Esra Turunç, Faruk Çiçekçi, Sedat Saylan, Alkin Çolak
- Study start
- 9 Oct 2023 (actual)
- Primary completion
- 30 Mar 2024 (actual)
- Study completion
- 1 Apr 2024 (actual)
- First posted
- 10 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 1 year to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
2 secondary outcomes
Risk factors for pediatric difficult SGA placement
Time frame: At the beginning of anesthesia
The incidence of complications related to SGA insertion
Time frame: Up to 24 hours after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
Related trials for Laryngeal Mask Airway
Not yet recruiting
Tizanidine Premedication Versus Placebo for Laryngeal Mask Airway Insertion and Recovery in Adults Undergoing Ambulatory Surgery
Airway Management
Not yet recruiting
Comparison of Second- and Third-Generation Laryngeal Mask Airway in Pediatric Patients
Airway Management, Anesthesia, General
Not yet recruiting
Effect of Laryngeal Mask Airway vs Endotracheal Tube on Hypothermia in Laparoscopic Hernia Surgery
Perioperative Hypothermia, Hernia, Inguinal
RecruitingPhase 4
Propofol-Ketamine Versus Sevoflurane for Laryngeal Mask Anesthesia in Pediatric Cardiac Catheterization
Propofol, Ketamine
Not yet recruitingPhase 4
Effect of Neuromuscular Blocking Agent Use on Video Laryngeal Mask Airway Insertion
Airway Management, Supraglottic Airway Device Insertion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alper Kilicaslan principal investigator
Necmettin Erbakan Universty Medical Faculty
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Laryngeal Mask Airway and Children, run by Alper Kilicaslan at 6 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2026.