NCT06602817

I-gel Plus Supraglottic Airway Device for Surgical Procedures in Prone Position

The I-gel Plus Supraglottic Airway Device for Elective Surgical Procedures in Prone Position

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 28 (actual)
• Sponsor: Universitätsklinikum Hamburg-Eppendorf · Academic / Other
• Sex: All
• Age: 18 Years – 89 Years
• Healthy volunteers: Not accepted

Summary

I-gel Plus is a novel supraglottic airway device that has been evaluated in various studies with high success and low complication rates. Feasibility of supraglottic airway devices (SGA) in patients undergoing surgery in prone position has been demonstrated in some pilot studies and case series; however, the evidence is still limited. It is currently uncertain, if the i-gel Plus facilitates appropriate ventilation in individuals undergoing elective surgery in prone position. The primary aim of this single-center non-inferior study is to assess the leak fraction of the i-gel Plus in patients undergoing surgery in prone position and to compare it with data from an existing prospective control cohort in patients undergoing surgery in supine position. Secondary aims are to investigate the oropharyngeal seal pressure and other secondary outcome parameters and to compare them with the control cohort.

Conditions

• General Anesthesia
• Airway Management
• Supraglottic Airway

Interventions

Type	Name	Description
OTHER	Exposure: prone position	Exposure: surgery in prone position
OTHER	Exposure: Supine position	Exposure: Surgery in supine position

Timeline

• Start date: 2024-10-01
• Primary completion: 2025-02-04
• Completion: 2025-02-04
• First posted: 2024-09-19
• Last updated: 2025-06-08

Locations

1 site across 1 country: Germany