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

NCT06602817 | Completed

• 1 other identifier: 2024-101343-BO-ff
• Study Type: observational
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

General Anesthesia; Airway Management; Supraglottic Airway

Keywords

Prone position; Surgery; Airway management

Outcome Measures

Primary Outcomes (1)

• Leak fraction

  Ventilation parameter - Leakage volume per tidal volume

  3 hours

Secondary Outcomes (18)

• Oropharyngeal seal pressure [cm H2O]

  3 hours

• Leakage volume (ml)

  3 hours

• Tidal volume (ml)

  3 hours

• Inspiratory peak pressure (cm H2O)

  3 hours

• Positive endexpiratory pressure (PEEP) (cm H2O)

  3 hours

Study Arms (2)

Surgery in prone position

Patients undergoing elective surgery in prone position with i-gel Plus used for airway management

Other: Exposure: prone position

Surgery in supine position

Existing prospective control cohort with patients undergoing elective surgery in supine position with i-gel Plus used for airway management

Other: Exposure: Supine position

Interventions

Exposure: prone position OTHER

Exposure: surgery in prone position

Surgery in prone position

Exposure: Supine position OTHER

Exposure: Surgery in supine position

Surgery in supine position

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 surgery in prone position with i-gel Plus used for airway management

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitätsklinikum Hamburg-Eppendorf: lead

Study Sites (1)

University Medical-Center Hamburg Eppendorf

Hamburg, Hamburg, 20246, Germany

Location

Study Officials

• Martin Petzoldt, MD

  University Medical Center Hamburg-Eppendorf: Universitatsklinikum 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 4, 2025
• Study Completion: February 4, 2025
• Last Updated: June 8, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)