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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Surgery in prone position | Patients undergoing elective surgery in prone position with i-gel Plus used for airway management |
| |
| Surgery in supine position | Existing prospective control cohort with patients undergoing elective surgery in supine position with i-gel Plus used for airway management |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exposure: prone position | Other | Exposure: surgery in prone position |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Leak fraction | Ventilation parameter - Leakage volume per tidal volume | 3 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Oropharyngeal seal pressure [cm H2O] | Clinical assessment - leak pressure with audible leak | 3 hours |
| 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 surgery in prone position with i-gel Plus used for airway management
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| Name | Affiliation | Role |
|---|---|---|
| Martin Petzoldt, MD | University Medical Center Hamburg-Eppendorf: Universitatsklinikum 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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| Exposure: Supine position |
| Other |
Exposure: Surgery in supine position |
|
| 3 hours |
| Tidal volume (ml) | Ventilation parameter - as displayed on the ventilator | 3 hours |
| Inspiratory peak pressure (cm H2O) | Ventilation parameter - as displayed on the ventilator | 3 hours |
| Positive endexpiratory pressure (PEEP) (cm H2O) | Ventilation parameter - as displayed on the ventilator | 3 hours |
| Respiratory rate (1/min) | Ventilation parameter - as displayed on the ventilator | 3 hours |
| Minute ventilation (l/min/kg) | Ventilation parameter -as displayed on the ventilator | 3 hours |
| Endtidal CO2 [mmHg] | Ventilation parameter - as displayed on the ventilator | 3 hours |
| Number of insertion attempts | Clinical assessment - SGA insertion attempts | 3 hours |
| Insertion success rate (%) | Clinical assessment | 3 hours |
| First-attempt insertion success rate (%) | Clinical assessment - successful placement in only one insertion attempt | 3 hours |
| Necessity of adjustment maneuvers during the procedure | Clinical assessment | 3 hours |
| Insertion time (sec) | Clinical assessment | 3 hours |
| Lowest oxygen saturation (%) | Measured by pulse oximetry | 3 hours |
| Difficulty of insertion | Clinical assessment on a scale between 1-5 | 3 hours |
| Ease of gastric tube insertion | Clinical assessment - rating on a scale from 1-5 | 3 hours |
| Postoperative complications | Clinical assessment | 24 hours postoperatively |
| Complications at the end of surgery | Clinical assessment | 3 hours |