I-gel Plus Supraglottic Airway Device for Elective Laparoscopic Surgery

I-gel Plus Supraglottic Airway Device for Elective Laparoscopic Surgery -a Prospective Observational Study-

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 Overview

• Status: Completed
• Conditions: Laparoscopic Surgery; Airway Management; General Anesthesia; Supraglottic Airway

• Study Type: Observational
• Enrollment (Actual): 48

Contacts and Locations

Study Locations

• Germany
  • Hamburg, Germany, 20246
    • University Medical Center Hamburg-Eppendorf

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing elective laparoscopic surgery with i-gel Plus used for airway management

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Patients undergoing laparoscopic surgery; Measurement of primary and secondary outcome parameters at different time points during the procedure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Leak fraction	Ventilation parameter - volume per tidal volume	3 houres

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oropharyngeal seal pressure [cm H2O]	Clinical assessment - leak pressure with audible leak	3 houres
Leakage volume (ml)	Ventilation parameter - as displayed on the ventilator	3 houres
Tidal volume (ml)	Ventilation parameter - as displayed on the ventilator	3 houres
Inspiratory peak pressure (cm H2O)	Ventilation parameter - as displayed on the ventilator	3 houres
Positive endexpiratory pressure (PEEP) (cm H2O)	Ventilation parameter - as displayed on the ventilator	3 houres
Intraabdominal pressure under capnoperitoneum [mmHg]	Measured intraoperativ under capnoperitoneum [mmHg]	3 houres
Respiratory rate (1/min)	Ventilation parameter - as displayed on the ventilator	3 houres
Minute ventilation (l/min/kg)	Ventilation parameter - as displayed on the ventilator	3 houres
Endtidal CO2 [mmHg]	Ventilation parameter - as displayed on the ventilator	3 houres
Number of insertion attempts	Clinical assessment - SGA insertion attempts	3 houres
Insertion success rate (%)	Clinical assessment	3 houres
First-attempt insertion success rate (%)	Clinical assessment - successful placement in only one insertion attempt	3 houres
Necessity of adjustment maneuvers during the procedure	Clinical assessment	3 houres
Insertion time (sec)	Clinical assessment	3 houres
Lowest oxygen saturation (%)	Measured by pulse oximetry	3 houres
Difficulty of insertion	Clinical assessment on a scale between 1-5	3 houres
Ease of gastric tube insertion	Clinical assessment - rating on a scale from 1-5	3 houres
Postoperative complications	Clinical assessment	24 hours postoperatively
Complications at the end of surgery	Clinical assessment	3 hours

Collaborators and Investigators

• Sponsor: Universitätsklinikum Hamburg-Eppendorf
• Investigators: Principal Investigator: Martin Petzoldt, MD, Universitätsklinikum Hamburg-Eppendorf

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2024
• Primary Completion (Actual): February 3, 2025
• Study Completion (Actual): February 3, 2025

Study Registration Dates

• First Submitted: September 16, 2024
• First Submitted That Met QC Criteria: September 16, 2024
• First Posted (Actual): September 19, 2024

Study Record Updates

• Last Update Posted (Actual): June 8, 2025
• Last Update Submitted That Met QC Criteria: June 4, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Laparoscopic surgery; Airwaymanagement; Capnoperitoneum
• Other Study ID Numbers: 2024-101346-BO-ff

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No