University Medical Center Hamburg-Eppendorf
Hamburg, Free and Hanseatic City of Hamburg, 20246, Germany
NCT Number: NCT06602830
i-gel Plus is a novel supraglottic airway device (SGA). Feasibility of second-generation SGAs in patients undergoing elective laparoscopic surgery has been demonstrated in various studies. During laparoscopic surgery intrabdominal pressure is increased by capnoperitoneum and frequently minute ventilation has to be adopted to counteract hypercapnia, and higher inspiratory peak pressures have to be expected. It is uncertain, however, if the i-gel Plus facilitates appropriate ventilation with low leakage volumes in patients undergoing laparoscopic surgery.
The primary aim of this single-center non-inferiority study is to assess the leak fraction of the i-gel Plus under conditions of capnoperitoneum (with and without Trendelenburg position) and to compare it with baseline conditions. Secondary aims are to assess secondary outcome parameters during capnoperitoneum (with and without Trendelenburg position) and to compare them with baseline conditions.
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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
Time frame: 3 houres
Ventilation parameter - volume per tidal volume
Time frame: 3 houres
Clinical assessment - leak pressure with audible leak
Time frame: 3 houres
Ventilation parameter - as displayed on the ventilator
Time frame: 3 houres
Ventilation parameter - as displayed on the ventilator
Time frame: 3 houres
Ventilation parameter - as displayed on the ventilator
Time frame: 3 houres
Ventilation parameter - as displayed on the ventilator
Time frame: 3 houres
Measured intraoperativ under capnoperitoneum [mmHg]
Time frame: 3 houres
Ventilation parameter - as displayed on the ventilator
Time frame: 3 houres
Ventilation parameter - as displayed on the ventilator
Time frame: 3 houres
Ventilation parameter - as displayed on the ventilator
Time frame: 3 houres
Clinical assessment - SGA insertion attempts
Time frame: 3 houres
Clinical assessment
Time frame: 3 houres
Clinical assessment - successful placement in only one insertion attempt
Time frame: 3 houres
Clinical assessment
Time frame: 3 houres
Clinical assessment
Time frame: 3 houres
Measured by pulse oximetry
Time frame: 3 houres
Clinical assessment on a scale between 1-5
Time frame: 3 houres
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
I-gel Plus Supraglottic Airway Device for Elective Laparoscopic Surgery -a Prospective Observational Study-
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