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Completed

NCT Number: NCT06602830

I-gel Plus Supraglottic Airway Device for Elective Laparoscopic Surgery

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.

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Key information

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Medical Center Hamburg-Eppendorf

Hamburg, Free and Hanseatic City of Hamburg, 20246, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Leak fraction

    Time frame: 3 houres

    Ventilation parameter - volume per tidal volume

Secondary outcomes

  1. Oropharyngeal seal pressure [cm H2O]

    Time frame: 3 houres

    Clinical assessment - leak pressure with audible leak

  2. Leakage volume (ml)

    Time frame: 3 houres

    Ventilation parameter - as displayed on the ventilator

  3. Tidal volume (ml)

    Time frame: 3 houres

    Ventilation parameter - as displayed on the ventilator

  4. Inspiratory peak pressure (cm H2O)

    Time frame: 3 houres

    Ventilation parameter - as displayed on the ventilator

  5. Positive endexpiratory pressure (PEEP) (cm H2O)

    Time frame: 3 houres

    Ventilation parameter - as displayed on the ventilator

  6. Intraabdominal pressure under capnoperitoneum [mmHg]

    Time frame: 3 houres

    Measured intraoperativ under capnoperitoneum [mmHg]

  7. Respiratory rate (1/min)

    Time frame: 3 houres

    Ventilation parameter - as displayed on the ventilator

  8. Minute ventilation (l/min/kg)

    Time frame: 3 houres

    Ventilation parameter - as displayed on the ventilator

  9. Endtidal CO2 [mmHg]

    Time frame: 3 houres

    Ventilation parameter - as displayed on the ventilator

  10. Number of insertion attempts

    Time frame: 3 houres

    Clinical assessment - SGA insertion attempts

  11. Insertion success rate (%)

    Time frame: 3 houres

    Clinical assessment

  12. First-attempt insertion success rate (%)

    Time frame: 3 houres

    Clinical assessment - successful placement in only one insertion attempt

  13. Necessity of adjustment maneuvers during the procedure

    Time frame: 3 houres

    Clinical assessment

  14. Insertion time (sec)

    Time frame: 3 houres

    Clinical assessment

  15. Lowest oxygen saturation (%)

    Time frame: 3 houres

    Measured by pulse oximetry

  16. Difficulty of insertion

    Time frame: 3 houres

    Clinical assessment on a scale between 1-5

  17. Ease of gastric tube insertion

    Time frame: 3 houres

    Clinical assessment - rating on a scale from 1-5

  18. Postoperative complications

    Time frame: 24 hours postoperatively

    Clinical assessment

  19. Complications at the end of surgery

    Time frame: 3 hours

    Clinical assessment

Sponsors and collaborators

Lead sponsor

Universitätsklinikum Hamburg-Eppendorf

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 19, 2024
Registry last updated
Jun 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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