I-gel Plus Supraglottic Airway Device for Elective Laparoscopic Surgery

Universitätsklinikum Hamburg-Eppendorf

Status: Completed

Conditions: Laparoscopic Surgery; Supraglottic Airway; General Anesthesia; Airway Management

Study type: Observational

Funder types: Other

Identifiers

NCT06602830

2024-101346-BO-ff

Details and patient eligibility

About

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.

Enrollment: 48 patients

Sex: All

Ages: 18 to 89 years old

Volunteers: No Healthy Volunteers

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

Trial design

48 participants in 1 patient group

Patients undergoing laparoscopic surgery

Description:

Measurement of primary and secondary outcome parameters at different time points during the procedure.