Observing challenges in placing airway devices in children
Risk Factors for Pediatric Difficult Supraglottic Airway Placement and Ventilation (PEDSGAP): A Multicentric Prospective Observational Study
This study looks at the challenges doctors face when trying to place breathing devices in children aged 1 to 12 during surgery to see what makes it difficult or leads to failures.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 3200 (estimated) |
| Ages | 1 Year to 12 Years |
| Sex | All |
| Sponsor | Konya Necmettin Erbakan Üniversitesi Academic / other |
| Locations | 2 sites (Konya and 1 other locations) |
| Trial ID | NCT06073977 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the difficulties and failures associated with the placement of supraglottic airway devices (SGAs) in pediatric patients aged 1 to 12 years undergoing elective surgery under general anesthesia. The study will collect data on the incidence of difficult or failed SGA placements and identify potential risk factors contributing to these challenges. By focusing on a multicentric approach, the research seeks to fill the knowledge gap regarding pediatric SGA use, which has been less studied compared to adults. Legal guardians will provide informed consent for participation in the study.
Who should consider this trial
Good fit: Ideal candidates are pediatric patients aged 1 to 12 years scheduled for elective surgery under general anesthesia where a supraglottic airway will be used.
Not a fit: Patients requiring oro-tracheal intubation or those with significant airway pathology or emergency surgeries may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the safety and effectiveness of airway management in pediatric surgeries.
How similar studies have performed: While there have been smaller studies on this topic, this prospective multicentric observational approach is relatively novel in the pediatric context.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Konya and 1 other locations
- Alper KILICASLAN — Konya, Turkey (Recruiting)
- Necmettin Erbakan University — Konya, Turkey (Recruiting)
Study contacts
- Principal investigator: Alper Kilicaslan — Necmettin Erbakan Universty Medical Faculty
- Study coordinator: Alper Kilicaslan
- Email: dralperkilicaslan@gmail.com
- Phone: +905053780376
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.