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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients undergoing laparoscopic surgery | Measurement of primary and secondary outcome parameters at different time points during the procedure. |
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| Measure | Description | Time Frame |
|---|---|---|
| Leak fraction | Ventilation parameter - volume per tidal volume | 3 houres |
| Measure | Description | Time Frame |
|---|---|---|
| Oropharyngeal seal pressure [cm H2O] | Clinical assessment - leak pressure with audible leak | 3 houres |
| Leakage volume (ml) | Ventilation parameter - as displayed on the ventilator |
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Inclusion Criteria:
Exclusion Criteria:
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Patients undergoing elective laparoscopic surgery with i-gel Plus used for airway management
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| Name | Affiliation | Role |
|---|---|---|
| Martin Petzoldt, MD | Universitätsklinikum Hamburg-Eppendorf | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Medical Center Hamburg-Eppendorf | Hamburg | Free and Hanseatic City of Hamburg | 20246 | Germany |
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| 3 houres |
| Tidal volume (ml) | Ventilation parameter - as displayed on the ventilator | 3 houres |
| Inspiratory peak pressure (cm H2O) | Ventilation parameter - as displayed on the ventilator | 3 houres |
| Positive endexpiratory pressure (PEEP) (cm H2O) | Ventilation parameter - as displayed on the ventilator | 3 houres |
| Intraabdominal pressure under capnoperitoneum [mmHg] | Measured intraoperativ under capnoperitoneum [mmHg] | 3 houres |
| Respiratory rate (1/min) | Ventilation parameter - as displayed on the ventilator | 3 houres |
| Minute ventilation (l/min/kg) | Ventilation parameter - as displayed on the ventilator | 3 houres |
| Endtidal CO2 [mmHg] | Ventilation parameter - as displayed on the ventilator | 3 houres |
| Number of insertion attempts | Clinical assessment - SGA insertion attempts | 3 houres |
| Insertion success rate (%) | Clinical assessment | 3 houres |
| First-attempt insertion success rate (%) | Clinical assessment - successful placement in only one insertion attempt | 3 houres |
| Necessity of adjustment maneuvers during the procedure | Clinical assessment | 3 houres |
| Insertion time (sec) | Clinical assessment | 3 houres |
| Lowest oxygen saturation (%) | Measured by pulse oximetry | 3 houres |
| Difficulty of insertion | Clinical assessment on a scale between 1-5 | 3 houres |
| Ease of gastric tube insertion | Clinical assessment - rating on a scale from 1-5 | 3 houres |
| Postoperative complications | Clinical assessment | 24 hours postoperatively |
| Complications at the end of surgery | Clinical assessment | 3 hours |