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PEDSGAP: Risk Factors for Pediatric Difficult Supraglottic Airway Placement and Ventilation

Sponsor
Konya Necmettin Erbakan Üniversitesi (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06073977
Collaborator
(none)
3,200
Enrollment
11.8
Anticipated Duration (Months)

Study Details

Study Description

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 infants and clarify the possible risk factors for difficulty.

Condition or Disease Intervention/Treatment Phase

    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

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    3200 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Risk Factors for Pediatric Difficult Supraglottic Airway Placement and Ventilation (PEDSGAP): A Multicentric Prospective Observational Study
    Anticipated Study Start Date :
    Oct 9, 2023
    Anticipated Primary Completion Date :
    Aug 30, 2024
    Anticipated Study Completion Date :
    Oct 1, 2024

    Outcome Measures

    Primary Outcome Measures

    1. The incidence of difficulty in supraglottic airway device(SGA) placement [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)

    Secondary Outcome Measures

    1. Risk factors for pediatric difficult SGA placement [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

    2. The incidence of complications related to SGA insertion [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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    1 Year to 12 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Konya Necmettin Erbakan Üniversitesi

    Investigators

    • Principal Investigator: Alper Kilicaslan, Necmettin Erbakan Universty Medical Faculty

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Alper Kilicaslan, MD,Professor of Anesthesiology, Konya Necmettin Erbakan Üniversitesi
    ClinicalTrials.gov Identifier:
    NCT06073977
    Other Study ID Numbers:
    • 2023/4546
    First Posted:
    Oct 10, 2023
    Last Update Posted:
    Oct 10, 2023
    Last Verified:
    Oct 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Alper Kilicaslan, MD,Professor of Anesthesiology, Konya Necmettin Erbakan Üniversitesi
    Supraglottic Airway
    Laryngeal Mask Airway
    Children
    Complication

    Study Results

    No Results Posted as of Oct 10, 2023