Evaluating the i-gel Plus airway device for surgeries in a face-down position
The I-gel Plus Supraglottic Airway Device for Elective Surgical Procedures in Prone Position
This study is testing how well the i-gel Plus airway device works for adults having surgery while lying face down, compared to when they are lying on their backs.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 28 (estimated) |
| Ages | 18 Years to 89 Years |
| Sex | All |
| Sponsor | Universitätsklinikum Hamburg-Eppendorf Academic / other |
| Locations | 1 site (Hamburg) |
| Trial ID | NCT06602817 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the effectiveness of the i-gel Plus supraglottic airway device in patients undergoing elective surgery in the prone position. It will measure the leak fraction of the device and compare it to data from patients in the supine position. The study will also evaluate oropharyngeal seal pressure and other secondary outcomes. The research is being conducted at a single center, focusing on adult patients with specific health criteria.
Who should consider this trial
Good fit: Ideal candidates include adult patients aged 18-89 scheduled for elective surgery in the prone position who require supraglottic airway management.
Not a fit: Patients who are pregnant, breastfeeding, or have contraindications for supraglottic mask ventilation will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve airway management techniques during surgeries performed in the prone position, enhancing patient safety and outcomes.
How similar studies have performed: Previous studies have shown promising results with supraglottic airway devices, but this specific approach in the prone position is still being evaluated.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients scheduling for elective surgery in prone position * 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 * Shared airway or intracavity open surgery * 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 — University Medical Center Hamburg-Eppendorf: Universitatsklinikum 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.