I-gel Plus Supraglottic Airway Device for Elective Laparoscopic Surgery

Universitätsklinikum Hamburg-Eppendorf48 enrolled

Overview

i-gel Plus is a novel supraglottic airway device (SGA). Feasibility of second-generation SGAs in patients undergoing elective laparoscopic surgery has been demonstrated in various studies. During laparoscopic surgery intrabdominal pressure is increased by capnoperitoneum and frequently minute ventilation has to be adopted to counteract hypercapnia, and higher inspiratory peak pressures have to be expected. It is uncertain, however, if the i-gel Plus facilitates appropriate ventilation with low leakage volumes in patients undergoing laparoscopic surgery. The primary aim of this single-center non-inferiority study is to assess the leak fraction of the i-gel Plus under conditions of capnoperitoneum (with and without Trendelenburg position) and to compare it with baseline conditions. Secondary aims are to assess secondary outcome parameters during capnoperitoneum (with and without Trendelenburg position) and to compare them with baseline conditions.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Airway Management Supraglottic Airway General Anesthesia Laparoscopic Surgery

Eligibility

Sex: ALLMin age: 18 YearsMax age: 89 Years

Outcomes

Primary Outcomes

Leak fraction

Ventilation parameter - volume per tidal volume

Time frame: 3 houres

Secondary Outcomes

Oropharyngeal seal pressure [cm H2O]

Clinical assessment - leak pressure with audible leak

Time frame: 3 houres

Leakage volume (ml)