MedPath

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

Recruiting
Conditions
General Anesthesia
Airway Management
Supraglottic Airway
Registration Number
NCT06602817
Lead Sponsor
Universitätsklinikum Hamburg-Eppendorf
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
28
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
Read More
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
Read More

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Leak fraction3 hours

Ventilation parameter - Leakage volume per tidal volume

Secondary Outcome Measures
NameTimeMethod
Oropharyngeal seal pressure [cm H2O]3 hours

Clinical assessment - leak pressure with audible leak

Leakage volume (ml)3 hours

Ventilation parameter - as displayed on the ventilator

Minute ventilation (l/min/kg)3 hours

Ventilation parameter -as displayed on the ventilator

Tidal volume (ml)3 hours

Ventilation parameter - as displayed on the ventilator

Inspiratory peak pressure (cm H2O)3 hours

Ventilation parameter - as displayed on the ventilator

Positive endexpiratory pressure (PEEP) (cm H2O)3 hours

Ventilation parameter - as displayed on the ventilator

Respiratory rate (1/min)3 hours

Ventilation parameter - as displayed on the ventilator

Endtidal CO2 [mmHg]3 hours

Ventilation parameter - as displayed on the ventilator

Number of insertion attempts3 hours

Clinical assessment - SGA insertion attempts

Insertion success rate (%)3 hours

Clinical assessment

First-attempt insertion success rate (%)3 hours

Clinical assessment - successful placement in only one insertion attempt

Necessity of adjustment maneuvers during the procedure3 hours

Clinical assessment

Insertion time (sec)3 hours

Clinical assessment

Lowest oxygen saturation (%)3 hours

Measured by pulse oximetry

Postoperative complications24 hours postoperatively

Clinical assessment

Difficulty of insertion3 hours

Clinical assessment on a scale between 1-5

Ease of gastric tube insertion3 hours

Clinical assessment - rating on a scale from 1-5

Complications at the end of surgery3 hours

Clinical assessment

Trial Locations

Locations (1)

University Medical-Center Hamburg Eppendorf

🇩🇪

Hamburg, Germany

University Medical-Center Hamburg Eppendorf
🇩🇪Hamburg, Germany
Martin Petzoldt, MD
Contact
m.petzoldt@uke.de
004940741052415
Nils Meiswinkel, MD
Contact
n.meiswinkel@uke.de
004940741052415
© Copyright 2025. All Rights Reserved by MedPath