An observational study in General Anesthesia, Airway Management and Supraglottic Airway, sponsored by Universitätsklinikum Hamburg-Eppendorf. Completed at 1 site in Germany. Open to participants aged 18 Years to 89 Years. Per ClinicalTrials.gov, last updated 2025-06-08.
Sponsored by Universitätsklinikum Hamburg-Eppendorf · Observational
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.
Universitätsklinikum Hamburg-Eppendorf is the lead sponsor of 403 studies on the registry; 83 are open to participants now.
Counted across the registry records on this site, refreshed daily.
patients undergoing elective surgery in prone position with i-gel Plus used for airway management
Exclusion Criteria:
Patients undergoing elective surgery in prone position with i-gel Plus used for airway management
Other: Exposure: prone 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 prone position
Exposure: Surgery in supine position
Leak fraction
Ventilation parameter - Leakage volume per tidal volume
Time frame: 3 hours
Oropharyngeal seal pressure [cm H2O]
Clinical assessment - leak pressure with audible leak
Time frame: 3 hours
Leakage volume (ml)
Ventilation parameter - as displayed on the ventilator
Time frame: 3 hours
Tidal volume (ml)
Ventilation parameter - as displayed on the ventilator
Time frame: 3 hours
Inspiratory peak pressure (cm H2O)
Ventilation parameter - as displayed on the ventilator
Time frame: 3 hours
Positive endexpiratory pressure (PEEP) (cm H2O)
Ventilation parameter - as displayed on the ventilator
Time frame: 3 hours
Respiratory rate (1/min)
Ventilation parameter - as displayed on the ventilator
Time frame: 3 hours
Minute ventilation (l/min/kg)
Ventilation parameter -as displayed on the ventilator
Time frame: 3 hours
Endtidal CO2 [mmHg]
Ventilation parameter - as displayed on the ventilator
Time frame: 3 hours
Number of insertion attempts
Clinical assessment - SGA insertion attempts
Time frame: 3 hours
Insertion success rate (%)
Clinical assessment
Time frame: 3 hours
First-attempt insertion success rate (%)
Clinical assessment - successful placement in only one insertion attempt
Time frame: 3 hours
Necessity of adjustment maneuvers during the procedure
Clinical assessment
Time frame: 3 hours
Insertion time (sec)
Clinical assessment
Time frame: 3 hours
Lowest oxygen saturation (%)
Measured by pulse oximetry
Time frame: 3 hours
Difficulty of insertion
Clinical assessment on a scale between 1-5
Time frame: 3 hours
Ease of gastric tube insertion
Clinical assessment - rating on a scale from 1-5
Time frame: 3 hours
Postoperative complications
Clinical assessment
Time frame: 24 hours postoperatively
Complications at the end of surgery
Clinical assessment
Time frame: 3 hours
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.
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Universitätsklinikum Hamburg-Eppendorf