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

Universitätsklinikum Hamburg-Eppendorf28 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

General Anesthesia Airway Management Supraglottic Airway

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 89 Years

Medical Language ↔ Plain English

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) \&gt;35 kg/m2 * Inability to understand or sign informed consent

Outcomes

Primary Outcomes

Leak fraction

Ventilation parameter - Leakage volume per tidal volume

Time frame: 3 hours

Secondary Outcomes

Oropharyngeal seal pressure [cm H2O]

Clinical assessment - leak pressure with audible leak

Time frame: 3 hours

Leakage volume (ml)