Using i-gel Plus for airway management in laparoscopic surgery
I-gel Plus Supraglottic Airway Device for Elective Laparoscopic Surgery -a Prospective Observational Study-
This study is testing if the i-gel Plus airway device works well for helping adults breathe during laparoscopic surgeries, both when the body is tilted and when it's not.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 48 (estimated) |
| Ages | 18 Years to 89 Years |
| Sex | All |
| Sponsor | Universitätsklinikum Hamburg-Eppendorf Academic / other |
| Locations | 1 site (Hamburg) |
| Trial ID | NCT06602830 on ClinicalTrials.gov |
What this trial studies
This observational study evaluates the effectiveness of the i-gel Plus supraglottic airway device during elective laparoscopic surgeries. It aims to assess the leak fraction of the device under conditions of capnoperitoneum, both with and without the Trendelenburg position, and compare these results to baseline conditions. The study focuses on adult patients who are scheduled for surgery and will utilize a supraglottic airway for anesthesia management. By analyzing ventilation effectiveness, the study seeks to determine if the i-gel Plus can provide adequate airway management in this surgical context.
Who should consider this trial
Good fit: Ideal candidates are adult patients aged 18-89 scheduled for elective laparoscopic surgery requiring supraglottic airway management.
Not a fit: Patients who are pregnant, breastfeeding, or have a BMI over 35 kg/m2 may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve airway management techniques during laparoscopic surgeries, enhancing patient safety and outcomes.
How similar studies have performed: Previous studies have shown feasibility for second-generation supraglottic airway devices in similar surgical contexts, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients scheduling for elective laparoscopic surgery * Planned airway management using a SGA * Adult patients (age 18-89 years) * ASA physical status 1-3 Exclusion Criteria: * Pregnant or breastfeeding women * Non-fasted patients * Increased risk of aspiration or other contraindications for supraglottic mask ventilation * Body mass index (BMI) \>35 kg/m2 * Inability to understand or sign informed consent
Where this trial is running
Hamburg
- University Medical Center Hamburg-Eppendorf — Hamburg, Germany (Recruiting)
Study contacts
- Principal investigator: Martin Petzoldt, MD — Universitätsklinikum Hamburg-Eppendorf
- Study coordinator: Martin Petzoldt, MD
- Email: m.petzoldt@uke.de
- Phone: +49 15222815932
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.