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

The I-gel Plus Supraglottic Airway Device for Elective 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.

Study Overview

• Status: Completed
• Conditions: Airway Management; General Anesthesia; Supraglottic Airway
• Intervention / Treatment: Other: Exposure: prone position; Other: Exposure: Supine position

• Study Type: Observational
• Enrollment (Actual): 28

Contacts and Locations

Study Locations

• Germany
  • Hamburg, Germany, 20246
    • University Medical-Center Hamburg Eppendorf

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Surgery in prone position; Patients undergoing elective surgery in prone position with i-gel Plus used for airway management	Other: Exposure: prone position; Exposure: surgery in 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; Exposure: Surgery in supine position

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Leak fraction	Ventilation parameter - Leakage volume per tidal volume	3 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative complications	Clinical assessment	24 hours postoperatively
Complications at the end of surgery	Clinical assessment	3 hours
Oropharyngeal seal pressure [cm H2O]	Clinical assessment - leak pressure with audible leak	3 hours
Leakage volume (ml)	Ventilation parameter - as displayed on the ventilator	3 hours
Tidal volume (ml)	Ventilation parameter - as displayed on the ventilator	3 hours
Inspiratory peak pressure (cm H2O)	Ventilation parameter - as displayed on the ventilator	3 hours
Positive endexpiratory pressure (PEEP) (cm H2O)	Ventilation parameter - as displayed on the ventilator	3 hours
Respiratory rate (1/min)	Ventilation parameter - as displayed on the ventilator	3 hours
Minute ventilation (l/min/kg)	Ventilation parameter -as displayed on the ventilator	3 hours
Endtidal CO2 [mmHg]	Ventilation parameter - as displayed on the ventilator	3 hours
Number of insertion attempts	Clinical assessment - SGA insertion attempts	3 hours
Insertion success rate (%)	Clinical assessment	3 hours
First-attempt insertion success rate (%)	Clinical assessment - successful placement in only one insertion attempt	3 hours
Necessity of adjustment maneuvers during the procedure	Clinical assessment	3 hours
Insertion time (sec)	Clinical assessment	3 hours
Lowest oxygen saturation (%)	Measured by pulse oximetry	3 hours
Difficulty of insertion	Clinical assessment on a scale between 1-5	3 hours
Ease of gastric tube insertion	Clinical assessment - rating on a scale from 1-5	3 hours

Collaborators and Investigators

• Sponsor: Universitätsklinikum Hamburg-Eppendorf
• Investigators: Principal Investigator: Martin Petzoldt, MD, University Medical Center Hamburg-Eppendorf: Universitatsklinikum Hamburg-Eppendorf

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2024
• Primary Completion (Actual): February 4, 2025
• Study Completion (Actual): February 4, 2025

Study Registration Dates

• First Submitted: September 16, 2024
• First Submitted That Met QC Criteria: September 16, 2024
• First Posted (Actual): September 19, 2024

Study Record Updates

• Last Update Posted (Actual): June 8, 2025
• Last Update Submitted That Met QC Criteria: June 4, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Surgery; Prone position; Airway management
• Other Study ID Numbers: 2024-101343-BO-ff

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No