Airway Management, General Anesthesia, Laparoscopic Surgery, Supraglottic Airway
Conditions
Keywords
Airwaymanagement, Laparoscopic surgery, Capnoperitoneum
Brief summary
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.
Interventions
None listed
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 laparoscopic surgery * 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 * Body mass index (BMI) \>35 kg/m2 * Inability to understand or sign informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Leak fraction | 3 houres | Ventilation parameter - volume per tidal volume |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Leakage volume (ml) | 3 houres | Ventilation parameter - as displayed on the ventilator |
| Tidal volume (ml) | 3 houres | Ventilation parameter - as displayed on the ventilator |
| Inspiratory peak pressure (cm H2O) | 3 houres | Ventilation parameter - as displayed on the ventilator |
| Positive endexpiratory pressure (PEEP) (cm H2O) | 3 houres | Ventilation parameter - as displayed on the ventilator |
| Intraabdominal pressure under capnoperitoneum [mmHg] | 3 houres | Measured intraoperativ under capnoperitoneum \[mmHg\] |
| Respiratory rate (1/min) | 3 houres | Ventilation parameter - as displayed on the ventilator |
| Minute ventilation (l/min/kg) | 3 houres | Ventilation parameter - as displayed on the ventilator |
| Endtidal CO2 [mmHg] | 3 houres | Ventilation parameter - as displayed on the ventilator |
| Number of insertion attempts | 3 houres | Clinical assessment - SGA insertion attempts |
| Oropharyngeal seal pressure [cm H2O] | 3 houres | Clinical assessment - leak pressure with audible leak |
| First-attempt insertion success rate (%) | 3 houres | Clinical assessment - successful placement in only one insertion attempt |
| Necessity of adjustment maneuvers during the procedure | 3 houres | Clinical assessment |
| Insertion time (sec) | 3 houres | Clinical assessment |
| Lowest oxygen saturation (%) | 3 houres | Measured by pulse oximetry |
| Difficulty of insertion | 3 houres | Clinical assessment on a scale between 1-5 |
| Ease of gastric tube insertion | 3 houres | 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 houres | Clinical assessment |
Countries
Germany
Outcome results
None listed