I-gel Plus Supraglottic Airway Device for Elective Laparoscopic Surgery

Last updated: October 8, 2024
Sponsor: Universitätsklinikum Hamburg-Eppendorf
Overall Status: Active - Recruiting

Phase

N/A

Condition

Anesthesia

Treatment

N/A

Clinical Study ID

NCT06602830
2024-101346-BO-ff
  • Ages 18-89
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • Pregnant or breastfeeding women

  • Non-fasted patients

  • Increased risk of aspiration or other contraindications for supraglottic maskventilation

  • Body mass index (BMI) >35 kg/m2

  • Inability to understand or sign informed consent

Study Design

Total Participants: 48
Study Start date:
October 01, 2024
Estimated Completion Date:
January 31, 2025

Connect with a study center

  • University Medical Center Hamburg-Eppendorf

    Hamburg, 20246
    Germany

    Active - Recruiting

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