University Medical-Center Hamburg Eppendorf
Hamburg, Free and Hanseatic City of Hamburg, 20246, Germany
NCT Number: NCT06602817
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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Notify Me18 year–89 year
All sexes
Observational
Hamburg, Free and Hanseatic City of Hamburg, 20246, Germany
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Exposure: surgery in prone position
Exposure: Surgery in supine position
Time frame: 3 hours
Ventilation parameter - Leakage volume per tidal volume
Time frame: 3 hours
Clinical assessment - leak pressure with audible leak
Time frame: 3 hours
Ventilation parameter - as displayed on the ventilator
Time frame: 3 hours
Ventilation parameter - as displayed on the ventilator
Time frame: 3 hours
Ventilation parameter - as displayed on the ventilator
Time frame: 3 hours
Ventilation parameter - as displayed on the ventilator
Time frame: 3 hours
Ventilation parameter - as displayed on the ventilator
Time frame: 3 hours
Ventilation parameter -as displayed on the ventilator
Time frame: 3 hours
Ventilation parameter - as displayed on the ventilator
Time frame: 3 hours
Clinical assessment - SGA insertion attempts
Time frame: 3 hours
Clinical assessment
Time frame: 3 hours
Clinical assessment - successful placement in only one insertion attempt
Time frame: 3 hours
Clinical assessment
Time frame: 3 hours
Clinical assessment
Time frame: 3 hours
Measured by pulse oximetry
Time frame: 3 hours
Clinical assessment on a scale between 1-5
Time frame: 3 hours
Clinical assessment - rating on a scale from 1-5
Time frame: 24 hours postoperatively
Clinical assessment
Time frame: 3 hours
Clinical assessment
Universitätsklinikum Hamburg-Eppendorf
Other
The I-gel Plus Supraglottic Airway Device for Elective Surgical Procedures in Prone Position
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