Comparing two airway devices for minor urological procedures under general anesthesia
Laryngeal Mask Airway I-Gel and Laryngeal Mask Airway Protector for Minor Urological Procedures Under General Anesthesia in Adult Patients: A Randomized Comparative Study
This study is testing which of two airway devices, the iGel or the Protector, works better and safer for adults undergoing minor urological procedures with general anesthesia.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | Sismanoglio General Hospital Academic / other |
| Locations | 2 sites (Athens and 1 other locations) |
| Trial ID | NCT06825910 on ClinicalTrials.gov |
What this trial studies
This randomized comparative study evaluates the effectiveness and safety of two laryngeal mask airway devices, the iGel and the Protector, during minor urological procedures in adult patients under general anesthesia. Participants will be randomly assigned to receive either the iGel or the Protector device. The study aims to assess not only the performance of these devices but also any unwanted effects that may arise during the procedures. By comparing these two devices, the study seeks to determine which one provides better airway management in this specific surgical context.
Who should consider this trial
Good fit: Ideal candidates for this study are adult patients aged 18 and older with ASA I-II status undergoing minor urological procedures.
Not a fit: Patients with anatomical anomalies of the upper airway or a history of difficult intubation may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance airway management techniques during minor urological procedures, leading to improved patient safety and outcomes.
How similar studies have performed: Other studies have shown varying success with similar airway device comparisons, but this specific comparison is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * ASA I-II * Patients older than 18 years * Procedures in supine and lithotomy position Exclusion Criteria: * Tumors or anatomical anomalies of the upper airway * Known history of difficult intubation * Limited mouth opening less than 2cm * Decreased compliance of the lungs or the thoracic cage * Need of mechanical ventilation after the surgery
Where this trial is running
Athens and 1 other locations
- SismanoglioGH — Athens, Greece (Not_yet_recruiting)
- SismanoglioGH — Athens, Greece (Recruiting)
Study contacts
- Study coordinator: Maria Zozefin Nikolopoulou
- Email: mz.nikolopoulou@gmail.com
- Phone: +306987389354
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.