I-gel Plus Supraglottic Airway Device for Elective Laparoscopic Surgery

NCT06602830 | Completed

• 1 other identifier: 2024-101346-BO-ff
• Study Type: observational
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Airway Management; Supraglottic Airway; General Anesthesia; Laparoscopic Surgery

Keywords

Airwaymanagement; Laparoscopic surgery; Capnoperitoneum

Outcome Measures

Primary Outcomes (1)

• Leak fraction

  Ventilation parameter - volume per tidal volume

  3 houres

Secondary Outcomes (19)

• Oropharyngeal seal pressure [cm H2O]

  3 houres

• Leakage volume (ml)

  3 houres

• Tidal volume (ml)

  3 houres

• Inspiratory peak pressure (cm H2O)

  3 houres

• Positive endexpiratory pressure (PEEP) (cm H2O)

  3 houres

Study Arms (1)

Patients undergoing laparoscopic surgery

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

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Patients scheduling for elective laparoscopic surgery
• Planned airway management using a SGA
• Adult patients (age 18-89 years)
• ASA physical status 1-3

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitätsklinikum Hamburg-Eppendorf: lead

Study Sites (1)

University Medical Center Hamburg-Eppendorf

Hamburg, Hamburg, 20246, Germany

Location

Study Officials

• Martin Petzoldt, MD

  Universitätsklinikum Hamburg-Eppendorf

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2024
• First Posted: September 19, 2024
• Study Start: October 1, 2024
• Primary Completion: February 3, 2025
• Study Completion: February 3, 2025
• Last Updated: June 8, 2025

Record last verified: 2025-06

Locations

DE (1)