Airway Management, General Anesthesia, Supraglottic Airway
Conditions
Keywords
Prone position, Surgery, Airway management
Brief summary
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.
Interventions
OTHERExposure: prone position
Exposure: surgery in prone position
OTHERExposure: Supine position
Exposure: Surgery in supine position
Sponsors
Universitätsklinikum Hamburg-Eppendorf
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
No
Inclusion criteria
* Patients scheduling for elective surgery in prone position * Planned airway management using a SGA * Adult patients (age 18-89 years) * ASA physical status 1-3
Exclusion criteria
* Pregnant or breastfeeding women * Non-fasted patients * Increased risk of aspiration or other contraindications for supraglottic mask ventilation * Shared airway or intracavity open surgery * Body mass index (BMI) >35 kg/m2 * Inability to understand or sign informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Leak fraction | 3 hours | Ventilation parameter - Leakage volume per tidal volume |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Leakage volume (ml) | 3 hours | Ventilation parameter - as displayed on the ventilator |
| Tidal volume (ml) | 3 hours | Ventilation parameter - as displayed on the ventilator |
| Inspiratory peak pressure (cm H2O) | 3 hours | Ventilation parameter - as displayed on the ventilator |
| Positive endexpiratory pressure (PEEP) (cm H2O) | 3 hours | Ventilation parameter - as displayed on the ventilator |
| Respiratory rate (1/min) | 3 hours | Ventilation parameter - as displayed on the ventilator |
| Minute ventilation (l/min/kg) | 3 hours | Ventilation parameter -as displayed on the ventilator |
| Endtidal CO2 [mmHg] | 3 hours | Ventilation parameter - as displayed on the ventilator |
| Number of insertion attempts | 3 hours | Clinical assessment - SGA insertion attempts |
| Oropharyngeal seal pressure [cm H2O] | 3 hours | Clinical assessment - leak pressure with audible leak |
| First-attempt insertion success rate (%) | 3 hours | Clinical assessment - successful placement in only one insertion attempt |
| Necessity of adjustment maneuvers during the procedure | 3 hours | Clinical assessment |
| Insertion time (sec) | 3 hours | Clinical assessment |
| Lowest oxygen saturation (%) | 3 hours | Measured by pulse oximetry |
| Difficulty of insertion | 3 hours | Clinical assessment on a scale between 1-5 |
| Ease of gastric tube insertion | 3 hours | Clinical assessment - rating on a scale from 1-5 |
| Postoperative complications | 24 hours postoperatively | Clinical assessment |
| Complications at the end of surgery | 3 hours | Clinical assessment |
| Insertion success rate (%) | 3 hours | Clinical assessment |
Countries
Germany
Outcome results
None listed