Clinical trial NCT06073977: Risk Factors for Pediatric Difficult Supraglottic Airway Placement and Ventilation
Official title: Risk Factors for Pediatric Difficult Supraglottic Airway Placement and Ventilation (PEDSGAP): A Multicentric Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Laryngeal Mask Airway
Children
Airway Management
Keywords: Supraglottic Airway
Laryngeal Mask Airway
Children
Complication
Lead sponsor: Konya Necmettin Erbakan Üniversitesi
Sponsor class: OTHER
First posted: 2023-10-10
Enrollment: 3200
Sex: ALL
Minimum age (years): 1
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

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

Eligibility criteria: 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

Primary outcomes:
measure: The incidence of difficulty in supraglottic airway device(SGA) placement
timeFrame: Immediately after the attempt of insertion and up to the end of the surgery
Secondary outcomes:
measure: Risk factors for pediatric difficult SGA placement
timeFrame: At the beginning of anesthesia
measure: The incidence of complications related to SGA insertion
timeFrame: Up to 24 hours after surgery
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: Alper KILICASLAN
city: Konya
country: Turkey
facility: Necmettin Erbakan University
Study officials:
affiliation: Necmettin Erbakan Universty Medical Faculty
name: Alper Kilicaslan
role: PRINCIPAL_INVESTIGATOR
References: