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Completed

NCT Number: NCT06602817

I-gel Plus Supraglottic Airway Device for Surgical Procedures in Prone Position

I-gel Plus is a novel supraglottic airway device that has been evaluated in various studies with high success and low complication rates. Feasibility of supraglottic airway devices (SGA) in patients undergoing surgery in prone position has been demonstrated in some pilot studies and case series; however, the evidence is still limited. It is currently uncertain, if the i-gel Plus facilitates appropriate ventilation in individuals undergoing elective surgery in prone position.

The primary aim of this single-center non-inferior study is to assess the leak fraction of the i-gel Plus in patients undergoing surgery in prone position and to compare it with data from an existing prospective control cohort in patients undergoing surgery in supine position. Secondary aims are to investigate the oropharyngeal seal pressure and other secondary outcome parameters and to compare them with the control cohort.

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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 surgery in prone position
  • 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
  • Shared airway or intracavity open surgery
  • Body mass index (BMI) >35 kg/m2
  • Inability to understand or sign informed consent

Treatment and study plan

Exposure: prone position

Other

Exposure: surgery in prone position

Exposure: Supine position

Other

Exposure: Surgery in supine position

Primary outcomes

  1. Leak fraction

    Time frame: 3 hours

    Ventilation parameter - Leakage volume per tidal volume

Secondary outcomes

  1. Oropharyngeal seal pressure [cm H2O]

    Time frame: 3 hours

    Clinical assessment - leak pressure with audible leak

  2. Leakage volume (ml)

    Time frame: 3 hours

    Ventilation parameter - as displayed on the ventilator

  3. Tidal volume (ml)

    Time frame: 3 hours

    Ventilation parameter - as displayed on the ventilator

  4. Inspiratory peak pressure (cm H2O)

    Time frame: 3 hours

    Ventilation parameter - as displayed on the ventilator

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

    Time frame: 3 hours

    Ventilation parameter - as displayed on the ventilator

  6. Respiratory rate (1/min)

    Time frame: 3 hours

    Ventilation parameter - as displayed on the ventilator

  7. Minute ventilation (l/min/kg)

    Time frame: 3 hours

    Ventilation parameter -as displayed on the ventilator

  8. Endtidal CO2 [mmHg]

    Time frame: 3 hours

    Ventilation parameter - as displayed on the ventilator

  9. Number of insertion attempts

    Time frame: 3 hours

    Clinical assessment - SGA insertion attempts

  10. Insertion success rate (%)

    Time frame: 3 hours

    Clinical assessment

  11. First-attempt insertion success rate (%)

    Time frame: 3 hours

    Clinical assessment - successful placement in only one insertion attempt

  12. Necessity of adjustment maneuvers during the procedure

    Time frame: 3 hours

    Clinical assessment

  13. Insertion time (sec)

    Time frame: 3 hours

    Clinical assessment

  14. Lowest oxygen saturation (%)

    Time frame: 3 hours

    Measured by pulse oximetry

  15. Difficulty of insertion

    Time frame: 3 hours

    Clinical assessment on a scale between 1-5

  16. Ease of gastric tube insertion

    Time frame: 3 hours

    Clinical assessment - rating on a scale from 1-5

  17. Postoperative complications

    Time frame: 24 hours postoperatively

    Clinical assessment

  18. 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

The I-gel Plus Supraglottic Airway Device for Elective Surgical Procedures in Prone Position

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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